DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
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 10-12 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 10 recites a first and second mating structure. It is not clear if this is the same or different than the mating structure recited in claim 9. For purposes of the rejection, it is taken as the same.
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) 2-21 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Glenn (US 2007/0232997 A1).
With regard to claims 2-5, Glenn teaches a method of using a medical anchor system, comprising: releasing a medical instrument from an anchor device while a plurality of subcutaneous tines of the anchor device are positioned in a subcutaneous region through a skin penetration point ([0078] Fig. 1, member 20 considered as the instrument is released when member 70 is removed from 20, the tines are members 60 connected at end 40, extending away from each other in the non-folded condition in Fig. 2), wherein the anchor device comprises a retainer base having a first body portion and a second body portion foldable relative to the first body portion (Fig. 1 first and second members 60 connected at end 50); adjusting the anchor device from a non-folded condition to a folded condition by folding the second body portion relative to the first body portion such that the plurality of subcutaneous tines of the anchor device are generally adjacent to each other while a tip of each of the subcutaneous tines are positioned in the subcutaneous region through the skin penetration point (Fig. 2 is considered as the non-folded position, member 50 is adjusted to move members 60 to fold against 20 in a non-stressed, non-flexed, side-by-side shape, when the members are collapsed it is considered as folded, the members are adjacent and the tips are inserted); and removing the plurality of subcutaneous tines from the subcutaneous region through the skin penetration point while the anchor device is in the folded condition and the plurality of subcutaneous tines are generally adjacent to each other ([0078]).
With regard to claim 6, the tines would be removed before 20 as they are proximal to the distal end of 20.
With regard to claim 7, the proximal end of 20 proximal to tines 60 is removed prior to the removal of tines 60.
With regard to claims 8-10, see [0071] a clamp is fastened to 70 which must be removed prior to folding. A clamp necessarily has two surfaces taken as a mounting surface which would connect to two corresponding mating structures.
With regard to claims 11-13, the fold axis is parallel to the central axis of 20 and extends longitudinal through the flexible region about which members 60 fold, for purposes of the rejection it is taken as the axis to the left of 20. A clamp as recited above may be mated with surfaces on opposite sides of the fold axis.
With regard to claims 14-16 and 19, Glenn teaches a method of using a medical anchor system, comprising: folding an anchor device into a folded condition along a longitudinal fold axis such that a plurality of subcutaneous tines of the anchor device are generally adjacent to each other while the plurality of subcutaneous tines are positioned in a subcutaneous region through a skin penetration point ([0078] member 50 is adjusted to move members 60 connected at end 50, taken as the first and second body portions to fold against 20 along an axis parallel to 20 which extends longitudinal through the flexible region about which tine members 60 fold, for purposes of the rejection it is taken as the axis to the left of 20, tine members 60 are on opposite sides) when the members are collapsed it is considered as folded, the tines are considered as members 60 connected to 40 and are adjacent/side-by-side in the folded condition); and withdrawing the plurality of subcutaneous tines from the subcutaneous region through the skin penetration point while the anchor device is in the folded condition and the plurality of subcutaneous tines are generally adjacent to each other ([0078]).
With regard to claim 17, see [0071] a clamp is fastened to 70 which must be removed prior to folding.
With regard to claim 18, member 70 may be held to retain the anchor device in the folded condition.
With regard to claim 20, the tines would be removed before 20 as they are proximal to the distal end of 20.
With regard to claim 21, the proximal end of 20 proximal to tines 60 is removed prior to the removal of tines 21.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rosenberg et al. (US 2009/0099527 A1) cited on the IDS also discloses an anchor with foldable members with tines.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
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