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
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-18, drawn to a medical valve assembly, classified in A61B1/00068.
II. Claims 19-20, drawn to a medical valve stem, classified in A61M2039/224.
The inventions are distinct, each from the other because of the following reasons:
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because invention I does not require the valve stem have a one-way seal between a proximal opening and a gas inlet. The subcombination has separate utility such as a valve stem that does not require a valve body as described in claims 1 and 15, classified in A61M2039/224.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because at least the following reason(s) apply:
(a) the inventions require a different field of search due to their mutually exclusive characteristics (for example, searching different classes/subclasses or electronic resources, or employing different search queries) and the prior art applicable to one species would not likely be applicable to another invention.
(b) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention.
Upon election of either of Inventions I-II, a Species must be elected:
Species A: The device as described with reference to Figs.3e-g.
Species B: The device as described with reference to Figs.7-8.
These species are independent or distinct because they have mutually exclusive characteristics, thus having a search and/or examination burden by requiring different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries) and the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. Further, the prior art applicable to one species would not likely be applicable to another species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, no claims are held to be generic. Further, applicants are required to point out which claims correspond with which species, including new or amended claims.
There is a search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the species require a different field of search due to their mutually exclusive characteristics (for example, searching different classes/subclasses or electronic resources, or employing different search queries)
(b) the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of inventions (ii) an election of a species or a grouping of patentably indistinct species to be examined even though the requirement may be traversed (37 CFR 1.143). and (iii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During telephone conversations with Michael T. Hess on 12 August, 2026 and 4 September, 2026, a provisional election was made without traverse to prosecute the invention of Invention II (claims 19-20) and Species A (Figs.3e-g). Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-18 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention, and claims 19-20 are examined.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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 19-20 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 pre-AIA the applicant regards as the invention.
In regards to claim 19, the claim reads “the gas escape hole” [line 6]. There is insufficient antecedent basis for this limitation in the claim. Therefore, the claim is unclear. For the purposes of prosecution, and with reference to the applicant’s disclosure, it will be assumed this is the same as the proximal opening (see applicant’s Fig.4c).
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.
Claims 19-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Yabe (JPS 5949732A).
In regards to Claim 19, Yabe discloses a valve for a medical device, the valve comprising:
a valve stem configured to translate within a valve well between a first configuration and a second configuration, the valve stem comprising:
a proximal opening [Top opening of 64, Figs.3-4, page 4 lines 25-27 of the translation];
a gas inlet [65, Figs.3-4, page 4 lines 27-28]; and
a central lumen [64, Figs.3-4, page 4 lines 25-28] extending from the gas inlet to the gas escape hole [note the related 112 (b) rejection hereinabove]; and
a one-way seal [85, 87, Figs.3-4, page 5 lines 23-25, page 6 lines 8-10] extending circumferentially around the valve stem at an axial location along the valve stem distal of the proximal opening and proximal of the gas inlet, and
wherein the one-way seal is configured to contact a vertical inner wall of a valve well between a gas inlet [5a] of the valve well and a gas outlet [5b] of the valve well [Figs.3-4, note that the valve well, gas inlet and gas outlet are not positively claimed here.].
In regards to claim 20, Yabe discloses the valve of claim 19, further comprising:
an upper wiper seal [62, 82, Figs.3-4] extending circumferentially around the valve stem at an axial location proximal of the one-way seal, the upper wiper seal comprising first [62] and second [82] wipers; and
a lower wiper seal [93, Figs.3-4] extending circumferentially around the valve stem at an axial location distal of the one-way seal, the lower wiper seal comprising first [upper protrusion of 93, Figs.3-4] and second [lower protrusion of 93, Figs.3-4] wipers.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nakajima (US 4,800,869)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON B FAIRCHILD whose telephone number is (571)270-5276. The examiner can normally be reached 8:30am-5pm Monday-Friday.
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 Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON B FAIRCHILD/Primary Examiner, Art Unit 3795
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