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 .
Election/Restrictions
Applicant’s election without traverse of Species I (Figs. 1-9), and sub-species Ic (Figs. 4A-4D) in the reply filed on 02/06/26 is acknowledged.
Claims 3, 9, 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species II, sub-species Ia-b, d-h (Figs. 2A-3D, 5A-9), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/06/26.
Currently, claims 1-2, 4-8, 10-15 are being examined in this office action.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
It is desirable to avoid the submission of long lists of documents if it can be avoided. Clearly irrelevant and marginally pertinent cumulative information should be eliminated. If a long list is submitted, those documents which have been specifically brought to applicant's attention and/or are known to be of most significance should be highlighted. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), affd, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995). See MPEP 2004.
Applicant's duty of disclosure of material and information is not satisfied by presenting a patent examiner with "a mountain of largely irrelevant [material] from which he is presumed to have been able, with his expertise and with adequate time, to have found the critical [material]. It ignores the real world conditions under which examiners work. Applicant has a duty not just to disclose pertinent prior art references but to make a disclosure in such way as not to "bury" it within other disclosures of less relevant prior art; See Golden Valley Microwave Foods Inc. v. Weaver Popcorn Co. Inc., 24 USPQ2d 1801 (N.D. Ind. 1992); Molins PLC v. Textron Inc., 26 USPQ2d 1889, at 1899 (D.Del 1992); Penn Yan Boats, Inc. v. Sea Lark Boats, Inc. et al., 175 USPQ 260, at 272 (S.D. F1. 1972).
The examiner is not afforded the time to thoroughly review each reference of the three-IDS(es) of 07/27/23 (includes 8pages, 10 pages and 27 pages), given the number of references cited. By initialing each of the cited references on the accompanying 1449 form(s), the examiner is merely acknowledging the submission of the cited references and indicating that only a cursory review was made of the cited references.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5, 7-8 & 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claim 5, the limitation “wherein the first drive device comprises a first plurality of teeth operable to extend into the first plurality of protrusions of the first component, and wherein the second drive device comprises a second plurality of teeth operable to extend into the second plurality of protrusions of the second component” in claim 5 is failing to comply with the written description. The elected Fig. 4A shows that a teeth 417 of the drive device 415/416 engage into openings 444 of the first and second components 440 & 441. The protrusions 443 & 445 are in solid form, see Fig. 4B. How is possible that the teeth of the drive devices 415 & 417 are being extended into the protrusions 443 & 445 of the first and second components. Does Applicant mean that the teeth 417 of the first drive device 415 are engaged into the openings 444 of the first component 440 and the teeth 417 of the second drive device 416 are engaged into the openings 446 of the second component 436?
In claim 7, it requires that: wherein the first component has a first bend resistance in a first direction and a second bend resistance in a second direction, and wherein the first bend resistance in the first direction is greater than the second bend resistance in the second direction. Oppositely, the original specification states in para [0071] that: the first component 440 may have a first bend resistance in a first direction (e.g., +z direction) and a second bend resistance in a second direction (e.g., −z direction). In the embodiment shown, the first bend resistance in the first direction is less than the second bend resistance in the second direction.
In claim 8, it requires that: wherein the second component has a first bend resistance in the first direction and a second bend resistance in the second direction, and wherein the first bend resistance in the first direction is less than the second bend resistance in the second direction. Oppositely, the original specification states in para [0071] that: the second component 441 may have a first bend resistance in the first direction (e.g., +z direction) and a second bend resistance in the second direction (e.g., −z direction), wherein the first bend resistance in the first direction is greater than the second bend resistance in the second direction.
In claim 14, this claim is being rejected using same analysis as noted in the claims 7 & 8 above.
Claims 7-8 & 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The breadth of the claims:
Breadth of the limitation “... wherein the first bend resistance in the first direction is greater than the second bend resistance in the second direction” (in claim 7) and the limitation “wherein the first bend resistance in the first direction is less than the second bend resistance in the second direction “ (in claim 8)
The nature of the invention:
The first component has a first bend resistance in a first direction and second bent resistance in a second direction; the second component has a first bend resistance in a first direction and a second bend resistance in a second direction.
The state of the prior art:
The pump includes a drive mechanism includes two flexible portions to form a rigid plunger shaft; a transition mechanism (wheels) coupled to the flexible portions for guiding a direction change of the flexible portion from the first direction to the second direction.
The level of one of ordinary skill:
A medical professional with sufficient skill and experience in working in pump device with a drive mechanism in a drug delivery device area.
The level of predictability in the art:
Generally understood to be predictable with regards to the bend resistance in a first and second directions when the first and second wheels each having a plurality of teeth operable to engage respective first and second components.
A first and second bending resistances in the first and second component provide a lot of unknown variables, therefore highly unpredictable. The interpretation of results has been ambiguous.
The amount of direction provided by the inventor
The amount of direction presented was narrowly and no working examples directed to the first and second bending resistances in the first and second directions in the first and second components.
How are bending resistance values being measured so that to compare (greater than or less than) in between the first and second direction that happened in the first and second components, as recited in claims 7-8?
The existence of working examples
No working examples were provided for practicing the invention in the drive device of the first and second bending directions in the first and second components.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
As to the level of one of ordinary skill in the art, one could not make or use the invention with the provided disclosure. Due to the lack of any explanation on determining how to get the result of the level different of bend resistance in the first and second directions of the first and second components, one could not make or use the invention without undue experimentation.
Due to the failure of Applicant to adequately describe the invention, one would have to experiment unduly to reach the claimed result as required in claims 7-8 and thus the invention is not enabled.
In claim 14, this claim is being rejected using same analysis as noted in the claims 7-8 above.
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 7-8 & 14 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.
In claim 7, the limitation “wherein the first component has a first bend resistance in a first direction and a second bend resistance in a second direction, and wherein the first bend resistance in the first direction is greater than the second bend resistance in the second direction” is vague. It is unclear to Examiner that how is the bend resistance being measured so that to compare the different in between the first bend resistance being greater than the second bend resistance in the second direction?
In claim 8, the limitation “wherein the second component has a first bend resistance in the first direction and a second bend resistance in the second direction, and wherein the first bend resistance in the first direction is less than the second bend resistance in the second direction” is vague. It is unclear to Examiner that how is the bend resistance being measured so that to compare the different in between the first bend resistance in the first direction being less than the second bend resistance in the second direction?
It appears that the first and second components 440 & 441 have same size, the first and second wheels 414 & 415 have same size. It is unclear to Examiner that how is possible that: in the first component, the first bend resistance in the first direction is greater than the second resistance in the second direction? Oppositely, how is possible that: in the second component, the first bend resistance in the first direction is less than the second resistance in the second direction?
In claim 14, this claim is being rejected using same analysis as noted in the claims 7-8 above.
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 1-2, 4, 6, 10-13 & 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braeuninger-Weimer et al. (US 6,488,183, called Weimer).
Regarding claim 1, Weimer discloses a wearable drug delivery device 1, Figs. 1-6 comprising:
a reservoir 15 configured to store a fluid 23, the reservoir 15 comprising a housing 5 (or 15) defining an interior chamber 5a/5b (or 23);
a drive device (e.g., a whole unit in Fig. 1 or Fig. 2 or elements #9, 11, 13, 21) for driving the fluid from the reservoir, the drive device comprising:
a plunger head AC/21 within the interior chamber of the housing; and
a plunger shaft G/9a/9b extending from the plunger head AC/21, wherein the plunger shaft comprises a first component U1/9a adjacent a second component U2/9b, and wherein during movement of the plunger head AC/21 in a first direction (arrow AD in Dif. 1) the first and second components engage one another to form a rigid portion C/33 of the plunger shaft.
Regarding claim 2, wherein the first component U1/9a comprises a first plurality of protrusions 11a and a first plurality of indentations (openings are located in between the intermeshing teeth 11a), wherein the second component U2/9b comprises a second plurality of protrusions 11b and a second plurality of indentations (openings are located in between the intermeshing teeth 11b), wherein the first plurality of protrusions are operable to engage the second plurality of indentations, and wherein the second plurality of protrusions are operable to engage the first plurality of indentations, see Fig. 1, 3 & 6.
Regarding claim 4, further comprising a first drive device T/13a engaged with the first component U1/9a and a second drive device T/9b engaged with the second component U2/9b, wherein the first and second drive devices T-T/13a-13b are rotatable to advance (arrow AD in Fig. 1 or Fig. 3) and retract (e.g., opposite direction with respect to arrow AD, or see Fig. 2, also see col. 6, lines 18-20) the first and second components relative to the housing of the reservoir.
Regarding claim 6, wherein the first component U1/9a is a strip of material having a curved profile defining a first crest (at 11a region, as shown in Fig. 6), wherein the second component U2/9b is a strip of material having a curved profile defining a second crest (at 11b region, as shown in Fig. 6), and wherein the first and second crests engage one another to form the rigid portion C/33 of the plunger shaft.
Regarding claim 10, wherein the first and second components U1-U2/9a-9b each include a first end opposite a second end, wherein the first end is coupled to the plunger head AC/21, and wherein the second end extends along an exterior of the housing of the reservoir, see Fig. 2.
Regarding claim 11, Weimer discloses a drive device of a wearable drug delivery device 1, Figs. 1-6 comprising:
plunger head AC/21 in contact with an interior surface of a housing 15 of a reservoir 15, see Fig. 6, the reservoir configured to store a fluid 23; and
a plunger shaft G/9a-9b extending from the plunger head AC/21, wherein the plunger shaft G/9a-9b comprises a first component U1/9a adjacent a second component U2/9b,
and wherein during movement of the plunger head AC/21 in a first direction (arrow AD in Dif. 1) the first and second components engage one another to form a rigid portion C/33 of the plunger shaft.
and wherein during movement of the plunger head in a second direction, opposite the first direction, the first and second components are moved away from one another, Fig. 2.
Regarding claims 12-13, these claims are being rejected using the same analysis as noted in the claims 2 & 6 above.
Regarding claim 15, further comprising a first pinion (1st wheel) T/13a engaged with the first component U1/9a and a second pinions (2nd wheel) T/13b engaged with the second component U2/9b, wherein the first and second pinions are rotatable (see arrows A in Fig. 1) to advance and retract the first and second components relative to the housing of the reservoir.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Braeuninger-Weimer et al. (US 6,488,183, called Weimer) in view of Choi (US 2017/0049968).
Regarding claim 5, Weimer discloses all the claimed subject matter as required except for that the first drive device comprises a first plurality of teeth operable to extend into the first plurality of protrusions of the first component, and wherein the second drive device comprises a second plurality of teeth operable to extend into the second plurality of protrusions of the second component.
Choi discloses a drug delivery drive in Fig. 3 comprising: a cartridge 11; a plunger head 12; a flexible plunger shaft 120 comprises a component 120; a drive device 110 comprises a plurality of teeth 111 operable to extend into (or in between) the first plurality of protrusions 125 (Fig. 1) of the component 120, see Fig. 3.
Giving such a teaching by Choi, a person having ordinary skill in the art would have easily recognizes that modifying the first and second drive devices and the first and second components of Weimer with obtaining a first plurality of teeth of the first drive device being extended into (or in between) the first plurality of protrusion of the first component and a second plurality of teeth of the second drive device being extended into (or in between) the second plurality of protrusion of the second component, as taught by Choi, would provide the benefits of delivering a drive force of the rotation drive device to the piston effectively and precisely without being bent or twisted, para [0038] in Choi.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 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, Michael Tsai can be reached on 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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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783