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 with traverse of Group I, species IA (Fig. 1A) in the reply filed on 07/02/26 is acknowledged. The traversal is on the ground(s) that the groups are not patentably distinct and searching them together presents no undue burden to the examiner. This is not found persuasive. In point of view of Examiner, these groups are patentably distinct and require different search. In addition,
Examiner states on page 5 of Restriction/Election 05/06/26 that:
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Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, nor submit the evidence (as noted the above), the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Groups II-III & Species 1b-1f (Figs. 1B-2F), 2a-2i (Figs. 4A-4I) & 3a-3f (Figs. 6-11I), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/02/26.
Note: the claims 7-8 require that: the penetrable seal is a funnel shaped with one or more resealable flaps. This feature has been described in the non-elected Figs. 1C-1D, 2A-F. Therefore, the claims 7-8 are withdrawn.
Claims 1-6 are being examined in this office action.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The original specification describes that the inlet is a concave inlet. However, all of the figures show that the inlet is a convex inlet (e.g., outward curve, i.e., dome or cone shape), see the Exhibits #1-2 below.
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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 1-8 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.
The limitation “concave inlet” in claim 1 is failing to comply with the drawings in the original specification. For example: the Fig. 1A shows that the inlet 110 defines as outwardly curve, i.e. dome or cone shape. Therefore, the inlet 110 should be called as convex (see Exhibits #1-2 below), but not a concave inlet, as recited in the claim 1 and the specification.
Claims 2-8 are being rejected due to their dependency.
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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.
I) 1st set of rejection:
Claims 1-3 & 6 are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 10,426,940) in view of Baudino (US 6,044,304).
Aklog discloses an implantable device 130, Figs. 1D-1J, comprising:
a proximal portion 132 designed for subcutaneous placement, col. 6, line 5 (see similar Fig. 13P) said proximal portion including an inlet extending distally toward a first channel 140;
a distal portion 134 designed for intraosseous placement at a site of interest, (see similar Fig. 13P) said distal portion having a second channel 142/144 terminating in an opening and being co-axially aligned and in fluid communication with the first channel to define a pathway 138/140 from the proximal portion to the site of interest; and
a penetrable seal 150 (see Figs. 1G-1I) situated between the first channel and the second channel to minimize backflow from the site of interest into the proximal portion.
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Aklog does not disclose that the inlet defines as a concave inlet.
Baudino discloses an implantable device 100 comprising: a proximal portion 10 (Figs. 4-6) designed for subcutaneous placement (see similar Fig. 12), said proximal portion including an outward- curved inlet extending distally toward a first channel 25.
Note: as mentioned the above, the term “concave inlet” involves 112 issues. For examining purpose, Examiner interprets that the inlet is as an outward-curved inlet (that similar to an inlet 110 in the elected Fig. 1A of the current application)
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It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the inlet in the device of Aklog with obtaining an outward-curved inlet extending distally toward to a first channel, as taught by Baudino, in order to improve fluid dynamics and reduces medication buildup.
Regarding claim 2, Aklog in view of Baudino discloses all the claimed subject matter as required. Baudino discloses that wherein said outward-curved inlet has a surface defined by a rounded arc which is curved towards a central axis of the pathway 25 (or pathway 18/140 in the Aklog in view of Baudino’s device).
Regarding claim 3, Aklog in view of Baudino discloses all the claimed subject matter as required. Aklog discloses that wherein said distal portion further comprises one or more retention elements (threads 134) to assist the implantation and anchoring of the distal portion within bone.
Regarding claim 6, Aklog in view of Baudino discloses all the claimed subject matter as required. Aklog discloses that wherein the second channel includes a tapered inlet 142 at a proximal end.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 10,426,940) in view of Baudino (US 6,044,304) and further in view of Ensminger et al. (US 5,226,879)
Regarding claims 4-5, Aklog in view of Baudino discloses all the claimed subject matter as required except for the limitation as required in the claims 4-5.
Note: the implantable device in Aklog (Aklog in view of Baudino) in formed as one piece. Meanwhile, the claimed invention requires that the proximal portion and distal portion are being separated; wherein the proximal portion further comprises a recess at a distal end to receive at least one of the penetrable seal and a top end of the intraosseous portion; wherein the proximal portion further comprises overhanging ends encasing at least one of the penetrable seal and the top of the distal intraosseous portion. It would have been obvious to one having ordinary skill in the art, prior to the effective filling date of the claimed invention, was made to obtain in two separate pieces (proximal and distal portion are being separated or detachable), since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art.
Meanwhile, Ensminge discloses an implantable device 60 comprising: a proximal portion 12; a distal portion 18; wherein the proximal portion comprises a recess at a distal end (at inner thread portion) to receive at least one of the penetrable seal 34 and a top end of the distal portion; wherein the proximal portion further comprises overhanging ends (at inner thread portion of the proximal portion 12) encasing at least one of the penetrable seal and the top of the distal portion (at outer threads portion).
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It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Aklog in view of Baudino with obtaining the proximal portion and distal portion being detachable and attachable; wherein the recess at distal end receiving a penetrable seal and top end of the proximal portion, as taught by Ensminge, in order to achieve simplicity in construction and retain the penetrable seal firmly down into the reservoir portion.
II) 2nd set of rejection:
Claims 1-3 & 6 are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 10,426,940) in view of Stats et al. (US 7,959,615).
Aklog discloses an implantable device 130, Figs. 1D-1J, comprising:
a proximal portion 132 designed for subcutaneous placement, col. 6, line 5 (see similar Fig. 13P) said proximal portion including an inlet extending distally toward a first channel 140;
a distal portion 134 designed for intraosseous placement at a site of interest, (see similar Fig. 13P) said distal portion having a second channel 142/144 terminating in an opening and being co-axially aligned and in fluid communication with the first channel to define a pathway 138/140 from the proximal portion to the site of interest; and
a penetrable seal 150 (see Figs. 1G-1I) situated between the first channel and the second channel to minimize backflow from the site of interest into the proximal portion.
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Aklog does not disclose that the inlet defines as a concave inlet.
Stats discloses an implantable device 10 comprising: a proximal portion 32A (Fig. 17) designed for subcutaneous placement, said proximal portion including concave inlet 60 extending distally toward a first channel (wherein a septum 18 inserted therein), see Figs. 17 & 21.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the inlet in the device of Aklog with obtaining a concave inlet extending distally toward to a first channel, as taught by Stats, in order to improve fluid dynamics and reduces medication buildup and allow the feature to be perceived by palpation.
Regarding claim 2, Aklog in view of Stats discloses all the claimed subject matter as required. Stats discloses that wherein said concave inlet has a surface defined by a rounded arc which is curved towards a central axis of the pathway.
Regarding claim 3, Aklog in view of Stats discloses all the claimed subject matter as required. Aklog discloses that wherein said distal portion further comprises one or more retention elements (threads 134) to assist the implantation and anchoring of the distal portion within bone.
Regarding claim 6, Aklog in view of Stats discloses all the claimed subject matter as required. Aklog discloses that wherein the second channel includes a tapered inlet 142 at a proximal end.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (US 10,426,940) in view of Stats et al. (US 7,959,615) and further in view of Ensminger et al. (US 5,226,879)
Regarding claims 4-5, Aklog in view of Stats discloses all the claimed subject matter as required except for the limitation as required in the claims 4-5.
Note: the implantable device in Aklog (Aklog in view of Stats) in formed as one piece. Meanwhile, the claimed invention requires that the proximal portion and distal portion are being separated; wherein the proximal portion further comprises a recess at a distal end to receive at least one of the penetrable seal and a top end of the intraosseous portion; wherein the proximal portion further comprises overhanging ends encasing at least one of the penetrable seal and the top of the distal intraosseous portion. It would have been obvious to one having ordinary skill in the art, prior to the effective filling date of the claimed invention, was made to obtain in two separate pieces (proximal and distal portion are being separated or detachable), since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art.
Meanwhile, Ensminge discloses an implantable device 60 comprising: a proximal portion 12; a distal portion 18; wherein the proximal portion comprises a recess at a distal end (at inner thread portion) to receive at least one of the penetrable seal 34 and a top end of the distal portion; wherein the proximal portion further comprises overhanging ends (at inner thread portion of the proximal portion 12) encasing at least one of the penetrable seal and the top of the distal portion (at outer threads portion).
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It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Aklog in view of Stats with obtaining the proximal portion and distal portion being detachable and attachable; wherein the recess at distal end receiving a penetrable seal and top end of the proximal portion, as taught by Ensminge, in order to achieve simplicity in construction and retain the penetrable seal firmly down into the reservoir portion.
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
Prosecution Insights