DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 18-20 are objected to because of the following informalities: in line 5, “the a first opening” should read --a first opening--. Appropriate correction is required.
Claims not specifically referenced are objected to as being dependent on an objected to base claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11 and 11 of U.S. Patent No. 11,187,329. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 11 and 11 of U.S. Patent No. 11,187,329 anticipates Application claims 1 and 12. Accordingly, claims 1 and 12 are not patentability distinct from U.S. Patent No. 11,187,329 claims 11 and 11.
Please note that the relevant sections in U.S. Patent No. 11, 187, 329 are underlined.
Here, U.S. Patent No. 11, 187, 329 claim 11 requires:
A valve for use in a medical device, the medical device having a fluid inlet and a fluid outlet,
the valve comprising:
a valve stem having a lumen extending from a first opening at a proximal portion of a first radially-outer surface of the valve stem to a second opening at a distal end of the valve stem; and
a plurality of seals positioned relative to the valve stem,
wherein the valve stem and the plurality of seals are configured so that a fluid entering the fluid inlet is prevented from flowing to the fluid outlet in a first position of the valve stem and the plurality of seals relative to the fluid inlet and the fluid outlet; and
wherein the valve stem and the plurality of seals are configured so that a fluid entering the fluid inlet is flowable to the fluid outlet in a second position of the valve stem and the plurality of seals relative to the fluid inlet and the fluid outlet, the second position being more distal than the first position relative to the fluid inlet and the fluid outlet,
wherein the fluid inlet is a first fluid inlet and the fluid outlet is a first fluid outlet;
wherein the medical device further comprises a second fluid inlet and a second fluid outlet; wherein the plurality of seals includes a first seal, a second seal, a third seal, and a fourth seal; wherein:
the first seal is positioned proximal to the first opening and proximal to the first fluid outlet when the valve is in the first position and when the valve is in the second position;
the second seal is positioned distal to the first opening and proximal to the first fluid outlet when the valve is in the first position;
the second seal is positioned distal to the first opening and distal to the first fluid outlet when the valve is in the second position;
the third seal is positioned distal to the second fluid inlet and proximal to the second fluid outlet when the valve is in the first position and when the valve is in the second position; and
the fourth seal is positioned distal to the second fluid outlet and proximal to the first fluid inlet when the valve is in the first position and when the valve is in the second position;
wherein the lumen is a first lumen,
and the valve stem further comprises a second lumen extending from a third opening at a distal portion of the first lumen to a fourth opening at a distal portion of a second radially-outer surface of the valve stem, wherein the second lumen is transverse to the first lumen, and fluidly connects the first lumen with an area exterior to the valve stem;
wherein the valve further includes:
a face seal at the fourth opening of the second lumen, wherein the face seal is annular and is configured to form a slidable interference fit with a wall of the medical device so that a fluid is prevented from flowing between an area outside of the radially outer portion of the face seal and the fourth opening; and
an air seal coupled to a third radially-outer surface of the valve stem, wherein the air seal is configured to align with a second fluid inlet of the medical device when the valve is in the second position;
further comprising one or more threads protruding from a proximal portion of the exterior surface of the valve stem, and wherein, when each of the at least one thread are received by at least one groove of the medical device, the first opening is configured to align with the fluid outlet, the fourth opening is configured to align with the first fluid inlet, the air seal is configured to align with the second fluid inlet, and the valve is configured to be in the second position.
While, Application claim 1 requires:
A medical device, comprising:
a valve stem having a proximal end, a distal end, and a radial outer surface, the valve stem comprising:
a first opening;
a second opening;
a lumen in fluid communication with the first opening and the second opening; and
one or more external threads.
And Application claim 12 requires:
A medical device, comprising:
a valve cylinder, comprising:
one or more grooves;
one or more fluid inlets; and
one or more fluid outlets; and
a valve stem configured to be received in the valve cylinder, the valve stem comprising:
a first opening;
a second opening;
a lumen in fluid communication with the first opening and the second opening; and
one or more threads configured to engage the one or more grooves.
Thus, it is apparent that U.S. Patent No. 11,187,329 claims 11 and 11 encompasses Application claims 1 and 12, respectively. Following the rationale in In re Goodman cited in the preceding paragraph, wherein Applicant has once been granted a patent containing a claim for the specific or narrower invention, Applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer. Note that since U.S. Patent No. 11,187,329 anticipates Application claims 1 and 12, and since anticipation is the epitome of obviousness, then Application claims 1 and 12 are obvious over U.S. Patent No. 11,187,329.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 5-7, 9, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kondo (U.S. Patent No. 4,694,821).
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Annotated Figure 2 from Kondo, for claims 1-3, 5, 7, 9, 10.
Regarding claim 1, Kondo discloses:
A medical device (20), comprising:
a valve stem (41) having a proximal end (see annotated figure above), a distal end (see annotated figure above), and a radial outer surface, the valve stem (41) comprising:
a first opening (see annotated figure above)
a second opening (see annotated figure above)
a lumen (57, 58) in fluid communication with the first opening (see annotated figure above) and the second opening (see annotated figure above; Col. 6, lines 12-20)
one or more external threads 47
Regarding claim 2, Kondo discloses:
wherein the one or more external threads (47) are on the radial outer surface of the valve stem 41 (see Figure 2)
Regarding claim 3, Kondo discloses:
wherein the second opening (see annotated figure above) is proximal of the first opening (see annotated figure above) and the one or more external threads (47) are located proximal of the second opening (see annotated figure above)
Regarding claim 5, Kondo discloses:
wherein the first opening (see annotated figure above) is a distal opening axially aligned with a longitudinal axis of the lumen 57, 58 (see Figure 2)
Regarding claims 1 and 6, Kondo discloses:
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Annotated Figure 2 from Kondo for claim 6.
A medical device (20), comprising:
a valve stem (41) having a proximal end (see annotated figure above), a distal end (see annotated figure above), and a radial outer surface, the valve stem (41) comprising:
a first opening (see annotated figure above)
a second opening (see annotated figure above)
a lumen (57, 58) in fluid communication with the first opening (see annotated figure above) and the second opening (see annotated figure above; Col. 6, lines 12-20)
one or more external threads 47
wherein the first opening (see annotated figure above) faces radially outward through the radial outer surface
Regarding claim 7, Kondo discloses:
wherein the second opening (see annotated figure above) faces radially outward through the radial outer surface
Regarding claim 9, Kondo discloses:
a seal (50) on the radial outer surface and circumferentially surrounding the first opening (see annotated figure above)
Regarding claim 10, Kondo discloses:
a seal (50) on the radial outer surface at a location between the first opening (see annotated figure above) and the second opening (see annotated figure above), the seal is configured to seal around a perimeter of a fluid opening of a valve cylinder (30) configured to receive the valve stem 41
Claim(s) 1-3, 6, 7, 9, 10, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ricci et al. (U.S. 2006/0213564).
Regarding claim 1, Ricci discloses:
A medical device, comprising:
a valve stem (107) having a proximal end, a distal end, and a radial outer surface, the valve stem (107) comprising: (see paragraph 0023)
a first opening 185 (see paragraph 0023; see Figure 5A)
a second opening 183 (see paragraph 0023; see Figure 5A)
a lumen (181) in fluid communication with the first opening (185) and the second opening 183 (see paragraph 0023; see Figure 5A)
one or more external threads 215 (see paragraph 0025)
Regarding claim 2, Ricci discloses:
wherein the one or more external threads (215) are on the radial outer surface of the valve stem 107 (see paragraph 0025; see Figure 5A)
Regarding claim 3, Ricci discloses:
wherein the second opening (183) is proximal of the first opening (185) and the one or more external threads (215) are located proximal of the second opening 183
Regarding claim 6, Ricci discloses:
wherein the first opening (185) faces radially outward through the radial outer surface (see Figure 5A)
Regarding claim 7, Ricci discloses:
wherein the second opening (183) faces radially outward through the radial outer surface (see Figure 5A)
Regarding claim 9, Ricci discloses:
a seal (195’’’, 195’’’’) on the radial outer surface and circumferentially surrounding the first opening 185 (see Figure 5A)
Regarding claim 10, Ricci discloses:
a seal (195”) on the radial outer surface at a location between the first opening (185) and the second opening (183), the seal (195”) is configured to seal around a perimeter of a fluid opening of a valve cylinder (103, 219) configured to receive the valve stem 107 (see Figure 5A)
Regarding claim 12, Ricci discloses:
A medical device, comprising:
a valve cylinder (103, 219), comprising:
one or more grooves 217 (see paragraph 0025)
one or more fluid inlets 141 (see paragraph 0021)
one or more fluid outlets 143 (see paragraph 0021)
a valve stem (107) configured to be received in the valve cylinder (103, 219), the valve stem (107) comprising:
a first opening 185 (see paragraph 0023; see Figure 5A)
a second opening 183 (see paragraph 0023; see Figure 5A)
a lumen (181) in fluid communication with the first opening (185) and the second opening 183
one or more threads (215) configured to engage the one or more grooves 217 (see paragraph 0025)
Allowable Subject Matter
Claims 4, 8, 11, and 13-17 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.
Claims 18-20 are objected to above, but contain allowable subject matter.
The following is an examiner’s statement of reasons for indicating allowable subject matter: the prior art of record neither discloses nor makes obvious the combination set forth in claim 18.
Regarding claim 18, Ouchi (U.S. 2015/0011831) discloses a method, the method comprising: delivering air from an air inlet (37) in a valve cylinder to an air outlet (35) in the valve cylinder while a valve stem (32) in the valve cylinder is in a first position relative to the valve cylinder; rotating the valve stem (32) in the valve cylinder to a second position relative to the valve cylinder.
Ouchi fails to disclose a first opening of the valve stem is aligned with a water inlet of the valve cylinder and a second opening of the valve stem is aligned with the air outlet; and delivering water from the water inlet to the air outlet via the first opening and the second opening while the valve stem is in the second position.
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.”
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Suzuki et al. (U.S. 2017/0360278) discloses a medical device comprising a valve stem having a proximal and distal end, a radial outer surface, first and second openings, a lumen between the openings, and external threading; Ouchi (U.S. 2015/0011831) discloses a disc-shaped seal without a radially inner opening.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY E CARY whose telephone number is (571)272-9427. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
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/KELSEY E CARY/Primary Examiner, Art Unit 3753