DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/23/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
The “means for venting” as set forth in Claim 7 is being interpreted as set forth in paragraphs [0039] and [0040] of the instant application.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,278,311. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims substantially read on the claims of the instant application.
Instant Claim 1 maps to Patent Claim 1 (Instant Claim 1 is broader as it omits the “trocar” and “minimize severing” limitations in Patent Claim 1).
Instant Claim 2 maps to Patent Claim 1 (Instant Claim 2 adds the “minimizing severing” limitation present in Patent Claim 1).
Instant Claim 3 maps to Patent Claim 2.
Instant Claim 4 maps to Patent Claim 1 (Instant Claim 4 adds the “minimizing severing” limitations present in Patent Claim 1.
Instant Claim 5 maps to Patent Claim 3.
Instant Claim 6 maps to Patent Claim 1 (Instant Claim 6 adds “minimizing severing” limitations present in Patent Claim 1).
Instant Claim 7 maps to Patent Claim 7 (Instant Claim 7 is broader as it omits the “trocar” limitation found in Patent Claim 7).
Each of instant Claims 8-15 map to Patent Claims 8-15, respectively.
Instant Claim 16 maps to Patent Claims 7 and 16 (Instant Claim 16 adds the “trocar” and “trocar orientation” limitations found in Patent Claims 7 and 16).
Instant Claims 17-20 map to Patent Claims 5, 17, 6 and 18, respectively.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10278725. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims substantially read on the claims of the instant application.
Instant Claim 1 maps to Patent Claim 11 (specifically mapping the “window indicating orientation” to the “orientation marking”).
Instant Claim 2 maps to Patent Claim 13.
Instant Claim 4 maps to Patent Claim 4.
Instant Claim 6 amps to Patent Claim 13.
Instant Claim 16 maps to Patent Claim 1 (specifically the “trocar” limitation).
Instant Claim 17 maps to Patent Claims 1 and 11 (specifically the “depth marking” limitation).
Instant Claim 18 maps to Patent Claims 1 and 11.
Instant Claim 19 maps to Patent Claims 1 and 11 (specifically the “orientation marking” limitation).
Instant Claim 20 maps to Patent Claims 1 and 11.
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 3-6 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 Claims 3 and 5, the limitation “the transparent or translucent material” lacks proper antecedent basis because as set forth in Claim 1, the transparent or translucent limitation is recited as a “member” rather than a “material”. For purposes of examination the indefinite limitation has been deemed to claim that both the transparent or translucent materials/members are the same limitation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-6 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US 4645491 A to Evans.
Regarding Claim 1, Evans discloses a device for withdrawing or injecting fluid, comprising inter alia:
a cannula (needle 20a) having a beveled patient end (leading end 26a), a non-patient end (head portion 22a), an outer surface (surface of hollow stem portion 24a), and a central passage (space/passage formed within hollow stem portion 24a);
a first window (slot 28a) in the cannula extending from the outer surface to the central passage, said first window being spaced a predetermined distance from the cannula beveled patient end (as best seen in Fig. 4, the window begins a set predetermined distance from the leading end 26a); and
a transparent or translucent member disposed in said first window (transparent window 30a) (col. 3, lines 30-32 “…slot 28a could be filled by a transparent material, such as plastic, forming a window 30a which lies flush with the stem portion…”);
wherein the position of the first window in the cannula indicates the orientation of the cannula beveled patient end (since both the leading end 26a and slot 28a are fixed with respect to one another, as best seen below in Fig. 4, the slot 28a is capable of being used by an operator to indicate the orientation of the leading end 26a); and
wherein the first window is visible to an operator of the device to confirm a preferred orientation of the cannula beveled patient end (the slot 28a can be observed by an operator, therefore, the slot 28a is capable of being used by an operator to indicate the orientation of the leading end 26a).
Regarding Claim 2, Evans discloses the device of claim 1, wherein said preferred orientation of the cannula beveled patient end is provided when the bevel of the cannula beveled patient end is aligned relative to a patient body so as to minimize severing body fibers during insertion of the device into the patient body (the combination of the leading end 26a and slot 28a allow the leading end 26a to be aligned relative to a patient body so as to minimize severing body fibers during insertion of the device into the patient body, because the relative orientation of the leading end 26a can be known due to the fixed positioning between the slot 28a and leading end 26a).
Regarding Claim 3, Evans discloses the device of claim 1 wherein the transparent or translucent material is rendered visibly darker or lighter when spinal fluid is present within said cannula (since the slot 28a is provided with a transparent window 30a, when spinal fluid enters the space/passage formed within hollow stem portion 24a, the transparent window 30a would darken when fluid enters).
Regarding Claim 4, Evans discloses the device of claim 3, wherein said preferred orientation of the cannula beveled patient end is provided when the bevel of the cannula beveled patient end is aligned relative to a patient body so as to minimize severing body fibers during insertion of the device into the patient body (the combination of the leading end 26a and slot 28a allow the leading end 26a to be aligned relative to a patient body so as to minimize severing body fibers during insertion of the device into the patient body, because the relative orientation of the leading end 26a can be known due to the fixed positioning between the slot 28a and leading end 26a).
Regarding Claim 5, Evans discloses the device of claim 1 wherein the transparent or translucent material is rendered visibly darker or lighter when blood is present within said cannula (since the slot 28a is provided with a transparent window 30a, when spinal fluid enters the space/passage formed within hollow stem portion 24a, the transparent window 30a would darken when fluid enters).
Regarding Claim 6, Evans discloses the device of claim 5, wherein said preferred orientation of the cannula beveled patient end is provided when the bevel of the cannula beveled patient end is aligned relative to a patient body so as to minimize severing body fibers during insertion of the device into the patient body (the combination of the leading end 26a and slot 28a allow the leading end 26a to be aligned relative to a patient body so as to minimize severing body fibers during insertion of the device into the patient body, because the relative orientation of the leading end 26a can be known due to the fixed positioning between the slot 28a and leading end 26a).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim 17 and 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Evans in view of US 20080045857 to Miller et al. (hereinafter Miller).
Evans discloses the device of claim 1 except for expressly disclosing one or more depth/orientation markings on said cannula. However, Miller discloses at paragraph 0146 markings 104 that are disposed on an exterior portion of a cannula. Miller discloses at paragraph 0146 that these markings are used to indicate the depth and positioning of the cannula. One having an ordinary skill in the art at the time the invention was made would have found it obvious to modify the cannula of Torrie with the depth and orientation markings of Miller as Miller teaches in the Abstract that such markings would have optimized positioning and orientations to minimize trauma to the patient.
Allowable Subject Matter
Claim 7 is 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791