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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “manually actuated input” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claims 1 – 4, 6, 8, 12, and 15 are objected to because of the following informalities:
Claims 1, 2, 3, 8, 12, and 15 recite one or more of “the hollow needle” and/or “the needle” in various lines, although the lines are understood by the Examiner to mean “the generally hollow needle” as previously defined and repeated in various lines, the Examiner suggests that all lines (except for the initial line(s) “a generally hollow needle”) be amended to read either “the generally hollow needle”, “the hollow needle”, or “the needle” for the purpose of maintaining consistent language throughout the claims;
Claims 1, 8, and 15 recite “the distal end” in line 8, although the lines do not rise to the level of being indefinite as the “distal end” of the line is understood to be the “distal end” of the probe, the Examiner suggests the line be amended to read as “the distal end of the probe” or “the blunt distal end” for the purpose of maintaining consistent language throughout the claims;
Claims 1, 8, and 15 recite “the distal cutting end” in lines 8 and 14 (for each claim), although the lines are understood by the Examiner to mean “the cutting distal end” as previously defined, the Examiner suggests the lines be amended to read “the cutting distal end” for the purpose of maintaining consistent language throughout the claims;
Claims 1, 8, and 15 recite “a patient” in line 14, although the lines is understood by the Examiner to mean “the patient” as the “patient” was previously defined, the Examiner suggests the lines be amended to read “the patient” for the purpose of maintaining consistent language throughout the claims;
Claim 1 recites “wherein the wherein the” in line 14, however this appears to be a typographical error, thus the Examiner suggests the first or second “wherein the” be stricken out;
Claims 4 and 8 recite “against device advancement” in lines 2 and 16, respectively, although the lines are understood by the Examiner to mean “against the device advancement” as the “device” has been previously defined, the Examiner suggests the line be amended to read “against advancement of the device” for the purpose of maintaining consistent language throughout the claims;
Claim 6 recites “through it into a body cavity”, although the phrase “it” is understood by the Examiner to mean “the device” and the phrase “a body cavity” is understood by the Examiner to mean “the body cavity” as the “body cavity” was previously defined, the Examiner suggests the phrases be amended to read “the device” and “the body cavity”; additionally, for the purpose of being grammatically correct, the Examiner suggests the entire line be fully amended to read “though the device and into the body cavity”;
Claims 8 and 15 recite “configured to automatically halting distal movement” in line 12, however this is not grammatically correct. Thus, the Examiner suggests the lines be amended to read “configured to automatically halt distal movement”;
Appropriate correction is required.
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 limitation “means for biasing” in claims 1, 8, and 15. Furthermore, there are no structural modifiers either preceding or following the limitation. For the purpose of examination, the “means for biasing” in claims 1, 8, and 15 will be read as a spring (which is the disclosed corresponding structure, as described in paragraph [0016] of the instant specification) or an equivalent structure (which is any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way).
The limitation “means to reset the stabilizer” in claim 7. Furthermore, there are no structural modifiers either preceding or following the limitation. For the purpose of examination, the “means to reset the stabilizer” in claim 7 will be read as a spring coupled with a force, a push button, etc., (which is the disclosed corresponding structure, as described in paragraph [0022] of the instant specification) or an equivalent structure (which is any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way).
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
The generic placeholders are “connecting component” in claim 5 coupled to the functional language “configured to connect one or more devices”, “a resetting mechanism” in claim 8 coupled to the functional language “configured to reset the stabilizer”, “a resetting mechanism” in claim 9 coupled to the functional language “to cause the mechanical lock to disengage”, “a stabilizer resilient biasing mechanism” in claim 9 coupled to the language “to bias”. Furthermore, there are no structural modifiers either preceding or following the generic placeholders. For the purpose of examination, the “connecting component” in claim 5 will be read as a luer lock, etc., (which is the disclosed corresponding structure, as described in paragraph [0023] of the instant specification), the “a resetting mechanism” in claims 8 and 9 will be read as a spring coupled with a force, a push button, etc., (which is the disclosed corresponding structure, as described in paragraph [0022] of the instant specification), and the “a stabilizer resilient biasing mechanism” in claim 9 will be read as a spring (which is the disclosed corresponding structure, as described in paragraph [0022] of the instant specification) or an equivalent structures thereof (which are any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 7 and 9 – 12 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.
Claim 7 recites the limitation "the stabilizer" in line 1. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the phrase renders the claim indefinite because it is unclear if Applicant is intending for claim 7 to be dependent on claim 4 which provides antecedent basis for the “stabilizer” or if Applicant is intending for claim 7 to be dependent on claim 1, as it is currently, and for claim 7 to provide antecedent basis for the “stabilizer”. For the purpose of examination, the Examiner will read claim 7 to be dependent on claim 1, as it is currently, and the phrase as “a stabilizer”.
Regarding claim 9, the phrase "a resetting mechanism" renders the claim indefinite because it is unclear if Applicant is intending to define an additional “resetting mechanism” to the “resetting mechanism” previously defined in claim 8, or if Applicant is intending for the “resetting mechanism” to be the same “resetting mechanism” of claim 8. Based on Applicant’s disclosure, specifically, specification paragraph [0022], the Examiner will read the phrase to mean the later, such that the device of claim 9 contains a single “resetting mechanism”. In the event that Applicant is intending the former, the Examiner notes that claim 10 would be further indefinite as the phrase “the resetting mechanism” is unclear as to which “resetting mechanism” Applicant would be referring to.
Regarding claim 9, the phrase "it" renders the claim indefinite because it is unclear whether Applicant is intending for “it” to be a place holder for the “mechanical lock” or the “stabilizer”. Based on Applicant’s disclosure, specifically, specification paragraph [0022], the Examiner will read the phrase to mean the later, such that the “stabilizer is caused to reset” when biased by the “stabilizing resilient biasing member”.
Claims 10 – 12 are rejected as being indefinite for being dependent on an indefinite claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 8, 9, 13, and 14 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Donaldson et al (US 2014/0046303 A1) (herein referred to as Donaldson 2014’).
Regarding claims 8, 9, 13, and 14, Donaldson 2014’ discloses a device (device 10) for forming and/or maintaining an access pathway into a body of a patient (abstract, paragraphs [0042], [0089], [0103], [0107 – 0111], and Figs. 14 – 18), comprising:
a housing (holder 40) defining an open interior and having a proximal end and a distal end (paragraphs [0089], [0107] and Figs. 14 – 18), the housing including one or more openings (Figs. 14 – 18);
a generally hollow needle (needle 20) extending distally from the distal end of the housing (paragraphs [0089], [0107] and Figs. 14 – 18), the generally hollow needle having a cutting distal end (tip 22) (paragraph [0107]);
a probe (probe 50) slidably disposed within the generally hollow needle (claim 1), the probe having a blunt distal end and one or more openings adjacent to the distal end (paragraph [0042], Figs. 14 – 18, and claim 1);
means for biasing (biasing member/ spring 80) the distal end of the probe into a position distal to the distal cutting end of the hollow needle such that a force on the distal end of the probe can overcome the bias to move the probe proximally relative to the hollow needle (paragraphs [0094], [0108], [0110], Figs. 15 – 18, and claim 1);
a mechanical lock (phalanges 49) configured to automatically halting distal movement of the hollow needle and probe in response to the distal end of the probe returning to the position distal to the distal cutting end of the hollow needle upon the hollow needle entering a body cavity of a patient (paragraphs [0050], [0108 – 0110] and Figs. 16 – 18); and
a stabilizer (stabilizer 30) configured to provide counterforce against device advancement (paragraph [0110]); and
a resetting mechanism (holder 60) configured to reset the stabilizer to a more distal position (position in Fig. 16) relative to the distal end of the probe after initial use (paragraph [0107] and seen in progression from Fig. 16 to Fig. 18);
[claim 9] the resetting mechanism (holder 60) causes the mechanical lock (phalanges 49) to disengage with the stabilizer (stabilizer 30) such that, biased by a stabilizer resilient biasing mechanism (spring 84), it (the stabilizer 30) is caused to reset when the distal end of the probe is placed onto the patient (paragraph [0107] and seen in progression from Fig. 16 to Fig. 18);
[claim 13] wherein the resetting mechanism automatically resets the stabilizer once force is removed from a distal end of the stabilizer (Examiner’s note: when force is removed from the distal end of the stabilizer 30 the probe 50 will return to its original position and the spring 84 will automatically push the stabilizer distally, due to the spring force);
[claim 14] wherein the more distal position (position in Fig. 16) is an original position of the stabilizer relative to the distal position of the probe prior to use (see progression of the stabilizer 30 and the probe 50 from Fig. 16 to Fig. 18).
Claims 8, 9, 13, and 14 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Donaldson et al (US 2021/0106344 A1) (herein referred to as Donaldson 2021’).
Regarding claims 8, 9, 13, and 14, Donaldson 2021’ discloses a device (device 10) for forming and/or maintaining an access pathway into a body of a patient (abstract, paragraphs [0067], [0070 – 0074], and Figs. 1-3,7-10), comprising:
a housing (main body 50) defining an open interior and having a proximal end and a distal end (paragraphs [0067], [0070] and Figs. 1-3,7-10), the housing including one or more openings (Figs. 1-3,7-10);
a generally hollow needle (needle 30) extending distally from the distal end of the housing (paragraphs [0067], [0070] and Figs. 1-3,7-10), the generally hollow needle having a cutting distal end (tip 32) (paragraph [0071]);
a probe (stylet 20) slidably disposed within the generally hollow needle (paragraphs [0067], [0070 – 0074], and Figs. 1-3,7-10), the probe having a blunt distal end (paragraph [0037]) and one or more openings adjacent to the distal end (Figs. 1-3,7-10);
means for biasing (spring 54) the distal end of the probe into a position distal to the distal cutting end of the hollow needle such that a force on the distal end of the probe can overcome the bias to move the probe proximally relative to the hollow needle (paragraphs [0070 – 0072] and Figs. 7-10);
a mechanical lock (lock 55) configured to automatically halt distal movement of the hollow needle and probe in response to the distal end of the probe returning to the position distal to the distal cutting end of the hollow needle upon the hollow needle entering a body cavity of a patient (paragraphs [0069 – 0073], Figs. 7-10, and claim 1); and
a stabilizer (stabilizer 40) configured to provide counterforce against device advancement (paragraph [0072]); and
a resetting mechanism (key 52) configured to reset the stabilizer to a more distal position (position in Fig. 7) relative to the distal end of the probe after initial use (paragraphs [0070 – 0071] and seen in progression from Fig. 7 to Fig. 10);
[claim 9] the resetting mechanism (key 52) causes the mechanical lock (lock 55) to disengage with the stabilizer (stabilizer 40) such that, biased by a stabilizer resilient biasing mechanism (lock spring 56), it (the stabilizer 40) is caused to reset when the distal end of the probe is placed onto the patient (paragraphs [0070] and [0072]);
[claim 13] wherein the resetting mechanism (key 52) automatically resets the stabilizer once force is removed from a distal end of the stabilizer (paragraphs [0070 – 0071] and seen in progression from Fig. 7 to Fig. 10);
[claim 14] wherein the more distal position (position in Fig. 7) is an original position of the stabilizer (stabilizer 40) relative to the distal position of the probe (stylet 20) prior to use (see progression of the stabilizer 40 and the stylet 20 (i.e., the probe) from Fig. 7 to Fig. 10).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Donaldson et al (US 2021/0106344 A1) (herein referred to as Donaldson 2021’), as applied to claim 9 above, and further in view of Chen et al (US 2023/0064225 A1).
Regarding claims 10 and 11, as discussed above, Donaldson 2021’ discloses the device of claim 9.
However, Donaldson 2021’ is silent regarding (i) wherein the resetting mechanism includes a manually actuated button input.
As to the above, Chen teaches a device (vitrectomy probe 100; which equates to the device 10 of Donaldson 2021’) comprising a probe (which equates to the stylet 20 of Donaldson 2021’) within a stiffening sleeve 132 (which equates to the stabilizer 40 of Donaldson 2021’), and a mechanical lock (shaft 144; which equates to the lock 55 of Donaldson 2021’) and a resetting mechanism with a stabilizer resilient biasing mechanism (control member 138 with biasing device 149; which equates to the key 52 and spring 56 of Donaldson 2021’, respectively) to halt the movement and reset the position of the stiffening sleeve 132 relative to the probe, wherein the resetting mechanism is manually actuated input (abstract, paragraphs [0031], [0038], [0048 – 0053], and Fig. 4A,4B).
It should be understood that Donaldson 2021’ and Chen are known references in the art that teach a means for locking the movement of a longitudinal component relative to another with a means of resetting said component to its original position (abstract, paragraphs [0067], [0070 – 0074], and Figs. 1-3,7-10 – Donaldson 2021’ ; abstract, paragraphs [0031], [0038], [0048 – 0053], and Fig. 4A,4B – Chen); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one resetting mechanism for another, and the results of the substitution would have been predictable and resulted in the modified device of Donaldson 2021’ being able to function as intended to properly reset the position of the stabilizer as intended. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Claims 1 – 7 are rejected under 35 U.S.C. 103 as being unpatentable over Donaldson et al (US 2014/0046303 A1) (herein referred to as Donaldson 2014’) and in view of Gonzalez et al (US 2020/0100779 A1).
Regarding claims 1 and 3 – 7, Donaldson 2014’ discloses a device (device 10) for forming and/or maintaining an access pathway into a body of a patient (abstract, paragraphs [0042], [0089], [0103], [0107 – 0111], and Figs. 14 – 18), comprising:
a housing (holder 40) defining an open interior and having a proximal end and a distal end (paragraphs [0089], [0107] and Figs. 14 – 18), the housing including one or more openings (Figs. 14 – 18);
a generally hollow needle (needle 20) extending distally from the distal end of the housing (paragraphs [0089], [0107] and Figs. 14 – 18), the generally hollow needle having a cutting distal end (tip 22) (paragraph [0107]);
a probe (probe 50) slidably disposed within the generally hollow needle (claim 1), the probe having a blunt distal end and one or more openings adjacent to the distal end (paragraph [0042], Figs. 14 – 18, and claim 1);
means for biasing (biasing member/ spring 80) the distal end of the probe into a position distal to the distal cutting end of the hollow needle such that a force on the distal end of the probe can overcome the bias to move the probe proximally relative to the hollow needle (paragraphs [0094], [0108], [0110], Figs. 15 – 18, and claim 1);
a mechanical lock (phalanges 49) configured to automatically halt distal movement of the hollow needle and probe in response to the distal end of the probe returning to the position distal to the distal cutting end of the hollow needle upon the hollow needle entering a body cavity of a patient (paragraphs [0050], [0108 – 0110], [0120], and Figs. 16 – 18); and
[claim 4] a stabilizer (stabilizer 30) configured to provide counterforce against device advancement (paragraph [0110]);
[claim 5] a connecting component (cap 130) configured to connect to one or more attachment devices (paragraph [0118]);
[claim 6] wherein the device is configured to allow for gas insulation through it into a body cavity (Examiner’s note: it should be understood that the limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said, the structure of the prior art is capable of allowing gas insulation through the device and into a body cavity);
[claim 7] a means for resetting (holder 60) the stabilizer to a more distal position (position in Fig. 16) after initial use (paragraph [0107] and seen in progression from Fig. 16 to Fig. 18).
However, Donaldson 2014’ is silent regarding (i) [claim 1] wherein the wherein the needle is sufficiently less flexible than the probe to inhibit bending of the needle relative to the probe when lateral forces are applied to the needle, and (ii) [claim 3] wherein the needle comprises a material less flexible than a material of the probe.
As to the above, Gonzalez teaches, in the same field of endeavor, a device (device 20) comprising a housing (handle 24), a hollow needle (needle 36), and a probe (stylet 30) slidable within the needle (needle 36) (abstract, paragraphs [0036 – 0043], and Figs. 1.1-1.4), wherein the needle is rigid and made up of stainless steel and the probe is flexible and made up of nitinol (paragraph [0031] and [0034]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the needle and probe of Donaldson 2014’ to be made up of stainless steel and nitinol, respectively, based on the teachings of Gonzalez, as both stainless steel and nitinol are known materials known to form needles and probes that are used within the body; and one of ordinary skill in the art would have a reasonable expectation of success in making such a modification, such that the results would be predictable wherein the modified device is operable for its intended use.
Regarding claim 2, as discussed above, it would have been obvious to one of ordinary skill in the art to make the needle of Donaldson 2014’ less flexible than the probe, as taught by Gonzalez. However, the combination of Donaldson 2014’ and Gonzales is silent regarding the wall diameter of the needle relative to the wall diameter of the probe. As to the above, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle to have a thicker wall diameter than that of the probe since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the probe of Donaldson 2014’ would not operate differently with the claimed relative wall diameter, and since the probe is intended to reside within the needle to protect the probe, the probe having the claimed relative wall diameter the device would function appropriately having the claimed diameters.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Donaldson et al (US 2014/0046303 A1) (herein referred to as Donaldson 2014’).
Regarding claim 12, as discussed above, Donaldson 2014’ discloses the device of claim 9. Additionally, Donaldson 2014’ discloses wherein the stabilizer resilient biasing mechanism is a spring (spring 84) (paragraph [0107]).
However, Donaldson 2014’ is silent regarding (i) wherein the stabilizer resilient biasing mechanism / the spring is disposed around the needle that interfaces with the stabilizer.
As to the above, Donaldson 2014’ in paragraph [0120], recites wherein the specific arrangement of parts of the stabilizer is not critical to the overall function of the stabilizer and the resetting mechanism of the stabilizer such that other arrangements / configurations of the parts would work equally as well as the inherently disclosed arrangement. Therefore, the Examiner contends it would be obvious, and well within the purview, of one of ordinary skill in the art to move the spring 84 inside the space between the rods 32, below the bottom surface of the phalanges 49, and extending to the top of the bottom plate of the stabilizer, such that the spring 84 surrounds the needle and biases the top surface of the bottom plate portion of the stabilizer 30 distally (in the same manner that the spring 84 biases the rods 32 distally) such that in the absence of force the stabilizer will be reset to the more distal position relative to the probe 50, and that one of ordinary skill in the art would have a reasonable expectation of success in making such a modification, such that the results of the modification would be predictable and result in the modified device being operable for its intended use. The Examiner notes that this rejection is based on In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claims 15 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Donaldson et al (US 2014/0046303 A1) (herein referred to as Donaldson 2014’) and in view of Hughes (WO 2008/029109 A1) (see attached PDF).
Regarding claims 15 – 16, Donaldson 2014’ discloses a device (device 10) for forming and/or maintaining an access pathway into a body of a patient (abstract, paragraphs [0042], [0089], [0103], [0107 – 0111], and Figs. 14 – 18), comprising:
a housing (holder 40) defining an open interior and having a proximal end and a distal end (paragraphs [0089], [0107] and Figs. 14 – 18), the housing including one or more openings (Figs. 14 – 18);
a generally hollow needle (needle 20) extending distally from the distal end of the housing (paragraphs [0089], [0107] and Figs. 14 – 18), the generally hollow needle having a cutting distal end (tip 22) (paragraph [0107]);
a probe (probe 50) slidably disposed within the generally hollow needle (claim 1), the probe having a blunt distal end and one or more openings adjacent to the distal end (paragraph [0042], Figs. 14 – 18, and claim 1);
means for biasing (biasing member/ spring 80) the distal end of the probe into a position distal to the distal cutting end of the hollow needle such that a force on the distal end of the probe can overcome the bias to move the probe proximally relative to the hollow needle (paragraphs [0094], [0108], [0110], Figs. 15 – 18, and claim 1);
a mechanical lock (phalanges 49) configured to automatically halt distal movement of the hollow needle and probe in response to the distal end of the probe returning to the position distal to the distal cutting end of the hollow needle upon the hollow needle entering a body cavity of a patient (paragraphs [0050], [0108 – 0110], [0120], and Figs. 16 – 18); and
a check valve (check valve 100) disposed with a fluid flow path through the device (abstract, paragraphs [0042], [0103], and Figs. 15 – 18).
However, Donaldson 2014’ is silent regarding (i) [claims 15 and 16] the check valve being configured to provide an auditory alarm when air from within the body of the patient exits the check valve via the fluid flow path without the use of any other auditory component.
As to the above, Hughes teaches in the same field of endeavor, a device (pneumothorax apparatus) for forming an access path way (pathway to the pleural cavity) (abstract, page 2 paragraph 3 – page 3 paragraph 4, and Figs. 1,6,16) comprising a housing (housing 231), a hollow needle (needle 212), a probe (rod 230; which equates to the probe 20 of Donaldson 214’) slidable within the needle (page 8 paragraph 3 – page 9 paragraph 2, and Figs. 6,7), and a valve (duck-bill valve 71) configured to provide an auditory alarm (open and closing sound) when air from within the body of the patient exits the check valve via the fluid flow path without the use of any other auditory component for the purpose of indicating, to the user, that the pleural cavity has been reached / penetrated (page 2 paragraph 3 – page 3 paragraph 3, page 9 paragraph 2, and page 12 paragraph 3).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the check valve of Donaldson 2014’ to be configured to produce an audible alarm, based on the teachings of Hughes, for the purpose of indicating, to the user, that the pleural cavity has been reached / penetrated (page 2 paragraph 3 – page 3 paragraph 3 – Hughes).
Regarding claim 17, as discussed above, it would be obvious to modify the check valve of Donaldson 2014’ to incorporate an auditory alarm based on the teachings of Hughes. The combination further teaches wherein the check valve (check valve 100 of Donaldson 2014’; modified in view of Hughes) is configured such that the auditory alarm reliably occurs when there is tension pneumothorax (page 2 paragraph 3 – page 3 paragraph 3, page 9 paragraph 2, and page 12 paragraph 3 – Hughes) and does not occur in situations during which tension pneumothorax is not present (Examiner’s note: if there is no air / gas in the pleural space when the needle / probe are inserted therein, then there will be no air escaping through the check valve, and without any air escaping through the check valve, there will be no sound created by the air escaping through the check valve. Thus, the modified device is configured as claimed).
Regarding claim 18, as discussed above, it would be obvious to modify the check valve of Donaldson 2014’ to incorporate an auditory alarm based on the teachings of Hughes.
However the combination is silent regarding (i) wherein at a 1-meter distance from the sound source the auditory alarm has a detectable distinguishable acoustic indication sound level between 1000 Hz to 3500 Hz.
There is no evidence of record that establishes that changing the detectable distinguishable acoustic indication sound level at a 1 meter distance to be between 1000Hz and 3500Hz would result in a difference in function of the device of Donaldson 2014’ in view of Hughes. Further, a person having ordinary skill in the art, being faced with modifying the detectable distinguishable acoustic indication sound level of the device of Donaldson 2014’ in view of Hughes, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the detectable distinguishable acoustic indication sound level at 1 meter. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the indication sound level “may” be within the claimed range, and offering other acceptable ranges (specification at para. [0028]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the detectable distinguishable acoustic indication sound level at a 1 meter distance to be between 1000Hz and 3500Hz as an obvious matter of design choice within the skill of the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gerrone (US 5,312,351) teaches a device for forming/ maintaining an access pathway into a body comprising a housing, a hollow needle, a probe, and a stabilizer.
Contact Information
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/Andrew Restaino/Primary Examiner, Art Unit 3771