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 .
Response to Arguments
Applicant's arguments filed 07/30/26 have been fully considered but they are not persuasive.
On pages 5-6 regarding the 112f interpretation Applicant argues the claims do not invoke 112f since they do not use the term “means for”. Applicant then argues the structures that do represent the mobilization members are present in the specification, and states the claims should apply only on an element by element basis as is described by MEP 2181.
The Examiner respectfully points out claims need not use the terms “means for” in order to invoke 112f claim interpretation, as is noted in the office action of record. The Examiner also notes this action does interpret the claim on an element by element basis, making this argument unclear. The conclusion that the claims should not be interpreted under 112f have not been supported with sufficient argument or amendments to render this persuasive, and thus it is maintained.
On pages 7-8 Applicant argues amended claims overcome the rejection of the claims in view of Schwartz since they describe unitary surgical devices, as [0081] , [0107], and [0115] refer to the devices as unitary. Applicant concludes the Examiner cannot call panels 21, 24 as a “first” and a “second support” since they are integral and unitary.
The Examiner respectfully disagrees, noting the supports of Schwartz are considered to be separable via any means known (e.g. ripping, pulling, cutting, etc.). Further, the suggestion that a one-piece device cannot have two “supports” since the device itself is unitary is contrary to the Examiner’s understanding of a device having two parts pivoting relative to one another. These two parts, 21/24 can absolutely be called two supports.
On pages 8-9 Applicant argues further element 16g of Schwartz does not provide shear within the cavity since 16g and 18g are sutures which anchor the device to tissue and are not intended to move the parts relative to one another. Suggesting that the sutures could not generate shear since the panels 21, 24 are integral with one another and this would be impossible.
The Examiner respectfully agrees and withdraws the rejection of record.
On page 10 Applicant argues Kelly fails to teach a cavity since [0056] states the two scaffolds are not spaced from one another.
The Examiner respectfully agrees and withdraws the rejection of record.
On page 11 Applicant argues further Kelly does not teach the supports generating shear inside the cavity.
The Examiner respectfully disagrees, noting the supports appear to capable of generating sheer if moved in a manner conducive to generating shear. The structure of Kelly is not limited in any way from producing shear force as is being argued.
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.
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: “mobilization members” in claim 19.
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. These are understood to be either a handle (comprising a sleeve and a gripping part) constrained to rotate with the base and rotatable around the axis of rotation or a “mobilization lace” (specially defined by the specification as a “fastener (thread, cable, belt, etc.) fixed on a part of the device”) comprising a semi-rigid strand preferably made of a polymer material.
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.
Drawings
Figures 1a-b should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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 Objections
Claims 19, 26, 28-29, 33, 35, 38 are objected to because of the following informalities:
Claim 19 is objected to for referring to “biocompatible material” multiple times when it is unclear if the biocompatible material mentioned is the same or different from the previously mentioned biocompatible material.
Claim 26 is objected to for referring to the base being “substantially” perpendicular to the cylindrical side face when it is unclear what angles actually fall within the scope of being “substantially perpendicular”, for example as opposed to angles which are known to be perpendicular or not perpendicular. The specification does not appear to provide any guidance as regards what would fall within this term’s scope, meaning the scope of the claim cannot be determined. This may be a 112b rejection, if not clarified.
Claim 28 is objected to for referring to “an additional mobilization link” when it is unclear what this means. The claim (e.g. claim 19) refers to “a mobilization member”, and claim 27 states that mobilization member can be at least one mobilization lace. Since claim 28 next states the device further comprises “an additional mobilization link”, it is unclear if this is attempting to indicate that in addition to the multiple laces, there is also a mobilization link, or claim that the mobilization member can be both a link AND a lace at the same time, or whether the device can include one mobilization lace and one mobilization link, or some other interpretation. The specification does not appear to support any of these interpretations, leading the Examiner to question whether this is potentially new matter, or an attempt to combine multiple distinct embodiments into one, or whether this is just a potential 112b issue.
Claim 29 states the mobilization lace is “preferably” a strand made of polymer material, but it is unclear whether or not this is actually required in order to meet the limitations of claim 29. If it is, claim 30 might be objected to for failing to further limit claim 29. If it is not, it is unclear why it is present.
Claim 33 is objected to for referring to rigidity against “shear” multiple times in the claim, when it is unclear how, if at all, this relates back to the previously mentioned “shear” in claim 19.
The claim is further unclear for claiming the rigidity against shear at rigidifying elements is “strictly greater” than the rigidity in the central region. Merriam-Webster defines “strictly” as “in a strict manner : without latitude : closely, precisely, rigorously, stringently, positively”. However, since the term “greater than” already imparts a distinct requirement without latitude, it is unclear what this is intended to mean. For example, if the claim means the rigidity at the elements is “closely” greater (or “rigorously” greater, or “positively” greater, etc.) than the rigidity in a central region, it is unclear what it means to be closely (or rigorously or positively) greater.
Claim 35 states the graft is “preferably” a specific graft, but it is unclear whether or not this is actually required in order to meet the limitations of claim 35. If it is, claim 36 might be objected to for failing to further limit claim 35. If it is not, it is unclear why it is present.
Claim 38 is objected to for referring to “an individual” with improper antecedent basis.
Appropriate correction is required.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
Prosecution Insights