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) because they fail to show or detail a catheter and/or guidewire as described in the specification. No reference numbers are used to describe or detail specific features of the invention. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
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 1-3 are rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
The claim(s) are narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited.
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claims 1-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. It is not understood what the claimed invention is intended to be, i.e. the term “manager” implies some sort of controlling individual or application, nothing is recited to define what is intended by the term. Additionally the use of “device” is generic term that provides no specific structure whatsoever. This claim is an omnibus type claim.
Regarding claim 2, the phrase "whether …..or not" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. The intended use has alternatives which can possibly mean alternative structure, yet no features are recited to imply what they are. See MPEP § 2173.05(d).
In claim 3, the recitation of “different sizes and lengths” is vague and indefinite as to what these sizes and lengths are actually being referred to. Is the claimed invention a “kit” of different size and length elements? Or is some device possessing the ability to change its size and length? Further what size measurement is encompassed or what type of feature is meant to define the size? A diameter?
Applicant is reminded be careful to not add new matter.
Claim limitation “brain aneurysm manager” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “manager” is a generic word but includes an element that is arbitrary or undefined as recited in claim 1, so it is not clear what is performing the function exactly. It is also critical to point out that the term is ambiguous as one common and acceptable definition of the term “manager” is an individual who oversees some form of a system. Applicant is advised that it is not permissible to claim any human function under patent law as it could raise an issue under 35 U.S. C. 101. Thus it is suggested that all claims (1-3) be amended to clarify what is meant by “manager” as recited in the claims. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
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) 1,2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 109963531. Page 8 of translation describes apparatus to be delivered to treat or stop bleeding. Page 22 of translation discusses the treatment device is for an aneurysm. Also page 3 of translation states brain aneurysms can be managed. Regarding claim 2, page 2 of translation states prevention of rupture can be done with treatment device. Page 3 of translation discusses treatment of a ruptured brain aneurysm. Additionally page 5 of translation discusses treating ruptures and page 6 of translation discusses treatment devices.
Claim(s) 1,2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cragg et al. ( DE 69820105). Page 5 of translation describes apparatus to be delivered to treat or stop bleeding. Abstract of translation discusses the treatment device is for an aneurysm. Also pages 2,6 of translation states brain aneurysms can be managed.
Claim(s) 3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spector et al. (2020/0121482). Spector et al. disclose (paragraph 2) a treatment device or stent to treat an aneurysm and can be from a kit that provides a size and length to fit the artery (paragraph 79) size as well as the aneurysm, paragraph 174.
Claim(s) 3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cam et al. (2012/0296362). Cam et al. disclose (paragraph 82) a treatment device to treat an aneurysm and can be from a kit that provides a size and length to match the aneurysm. Cam et al. further disclose (paragraph 109) length and size can be selected based on the aneurysm.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Kish can be reached at 571-272-5554. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799