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 05/27/26 have been fully considered but they are not persuasive.
On page 9 regarding specification objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws specification objections.
On page 9 regarding drawing objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully withdraws the objections which were addressed. The remaining objections are maintained.
On pages 9 regarding the Examiner’s interpretation of the claims under 112f, Applicant disagrees the terms “tension adjusters” and “ratchet mechanism” fall under 112f interpretation.
The Examiner nevertheless maintains the interpretation of the claims under 112f.
On page 10 regarding 112b rejections Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws 112b rejections.
On pages 10-11 regarding prior art rejections Applicant argues amendments overcome the rejections of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Election/Restrictions
Claim 1 is allowable. The restriction requirement between species, as set forth in the Office action mailed on 04/20/26, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 04/20/26 is withdrawn. Claims 4-6, directed to a ratchet mechanism with teeth, are no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
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 passages, secondary passages, and two side regions opposite each other, each side section of the anterior segment, 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.
Claim Objections
Claims 1-12, 20-21 are objected to because of the following informalities:
Claim 1 is objected to for claiming “a…system adapted for implant at a native heart valve annulus” when this is grammatically incorrect.
The claim is further objected to for claiming “the filaments being connected to and displace a second one” which is grammatically incorrect.
Claim 4 is objected to for referring to “one segment” and “the other segment” with improper antecedent basis, and also for making it unclear whether or not these “segments” are related to the previously claimed “arcuate anterior segment” and “arcuate posterior segment”.
The claim is further objected to for referring to “side sections of the anterior segment”, and “two side section” of the posterior segment, as well as “each side”, when it is unclear how, if at all, these relate to the previously claimed “side regions”, if at all.
Claim 6 is objected to for referring to “one segment” and “the other segment” with improper antecedent basis, and also for making it unclear whether or not these “segments” are related to the previously claimed “arcuate anterior segment” and “arcuate posterior segment”.
Claim 8 is objected to for referring to “each of the side regions” when it is unclear whether this is referring to the side regions of the anterior segments, posterior segments, or of both the anterior and posterior segments.
Claim 9 is objected to for referring to “a left atrium” when it is unclear how this relates, if at all, to the previously claimed “heart”.
Claim 10 is objected to for not further limiting claim 1, from which it depends. The Examiner refers Applicant to the 112f claim interpretation section below, which indicates how this definition is read into claim 1.
Claim 11 is objected to for claiming “a…system adapted for implant at a native heart valve annulus” when this is grammatically incorrect.
The claim is further objected to for having improper antecedent basis for “a first one of the anterior or posterior segments” and “a second one of the anterior or posterior segments”, making it unclear if this is the same “a first one” and “a second one” of the segments that was previously identified in the claim.
Claim 12 is objected to for referring to “side sections” of the anterior segment when it is unclear how, if at all, this relates to the previously claimed “side regions”.
Claim 20 is objected to for not further limiting claim 1, from which it depends. The Examiner refers Applicant to the 112f claim interpretation section below, which indicates how this definition is read into claim 11.
Claim 21 is objected to for referring to “a left atrium” when it is unclear how this relates, if at all, to the previously claimed “heart”.
Remaining claims are objected to for depending on an objected claim.
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.
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: “pair of tension adjusters”, “ratchet mechanism” and “tension adjuster” in claims 1 and 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. The “tension adjusters” are considered to be “a rotating dial to adjust the tension on the associated adjustment filaments, and a gauge calibrated to indicate distance that the associated adjustment filament is displaced” ([0021]). The “ratchet mechanism” is considered to be “teeth on one segment engaging a detent on the other segment, or undulating bumps on one segment engaging mating undulating bumps on the other segment” ([0015]).
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 11-13, 19-21 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 pre-AIA the applicant regards as the invention.
Claim 11 is indefinite for claiming the adjustment filaments are adapted to pass through “a delivery system” but it is unclear how this delivery system relates to (if at all) the claimed “three-dimensional annuloplasty ring and shape adjustment system”. The specification makes it appear as if the shape adjustment system and delivery system might be the same thing, but the claim requires them to be different elements. The Examiner is unclear on how to interpret this claim.
Claim 19 is also indefinite for referring to “the delivery system” including “an access sheath” when it is unclear how, if at all, this relates to the previously claimed “three-dimensional annuloplasty ring and shape adjustment system”.
Remaining claims are rejected for depending on an indefinite claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 11, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madjarov et al. (WO 2014144439 A1) hereinafter known as Madjarov in view of Carpentier et al. (WO 9904730 A1) hereinafter known as Carpentier.
Regarding claim 11 Madjarov discloses a three-dimensional annuloplasty ring (Abstract; it is considered inherent for every structure to be three-dimensional) and shape adjustment system adapted for implant at a native heart valve annulus of a heart of a human body (page 2 line 35 – page 3 line 1),
wherein the ring defines a continuous peripheral shape (Figure 10) around a central aperture (Figure 10), and has an inner core (Figure 10 item 120) formed of an elastic-plastic material (The specification [0069] defines an “elastic-plastic material” as stainless steel, titanium alloy, nylon, polyamide, polyacetal, DERLIN polyoxymethylene (page 2 line 22)) and a suture-permeable interface surrounding the inner core and extending around the peripheral shape (Figure 10 item 150; page 2 lines 20-22, page 18 lines 3-9),
wherein the inner core has an arcuate anterior segment (Figure 10 the top segment (see also figure 9)) that overlaps an arcuate posterior segment (Figure 10 the bottom segment (see also figure 9)) at two side regions opposite each other (Figure 4), the peripheral shape being a rounded D-shape in plan view (Figure 4) where both the anterior and posterior segments rise up from the side regions to form a saddle shape (page 2, lines 33-34; page 17 lines 24-26; if the ring is corresponding to the shape of the mitral valve, the rising sides are on the anterior and posterior sides/segments),
wherein the anterior and posterior segments define a ratchet mechanism (teeth on one segment engaging a detent on the other segment, or undulating bumps on one segment engaging mating undulating bumps on the other segment (see Claim Interpretation above) (Figure 5a; page 8 lines 11-12)) at each side region such that a position of the segments relative to one another may be changed and the peripheral shape of the ring may be adjusted (page 7 lines 25-31), and
a pair of adjustment filaments (Figure 10a items 380, 385) adapted to pass through a delivery system (page 19 lines 14-18; their length is suitable to pass through a delivery system as the claim requires) and through passages in a first one of the anterior/posterior segments of the inner core (Figure 10a), the filaments being connected to and displace a second one of the anterior/posterior segments at the side regions to adjust the peripheral shape of the ring (page 18 lines 33-36; page 19 lines 20-23),
but is silent with regards to the ratchet mechanism including undulating bumps on one segment engaging undulating bumps on the other segment, and
a compression sleeve surround each of the side regions that hold the bumps relatively fixed until a predetermined threshold shear force is applied.
However, regarding claim 11 Carpentier teaches a ratchet mechanism that includes undulating bumps on two engaging segments (Figure 3a items 18, 20), and further teaches a sleeve surrounding each of the side regions that hold the bumps (page 6 lines 9-14 the ring can be covered in BOTH a stretchable/distensible sheath to prevent blood from entering into and or stagnating in spaces between articulating surfaces, AND a suture ring made of a needle (suture)-penetrable material) relatively fixed until a predetermined threshold shear force is applied (page 13 lines 3-9, the leaves are contained within a distensible outer sheath, the leaves cooperating with a complementary structure to allow expansion thereof; abstract: the teeth can be made of different sizes/shapes to regulate the amount of force needed to expand the ring at different stages; page 3 line 29-page 4 line 2 the ring is adapted to expand upon natural growth of the patient’s annulus or upon application of a dilation force, and the surrounding covering is radially expandable). While Carpentier isn’t clear whether or not the sleeve is a compression sleeve, the discussion of the ring/cover sheaths indicates that the ring stays at one size until appropriate force is applied to expand the ring, the ring radially expanding, and the cover/sheaths radially expanding therewith. If the ring is not considered a “compression sleeve” at a smallest diameter of the ring, for example, the sleeve will begin to compress the underlying features relatively more than previously (inherently) when it is expanded. Thus, the Examiner understands the surrounding sleeve which includes multiple layers to both be a suture-permeable interface and ensure blood does not enter into articulating spaces to be inherently, or at the very least obviously, a compression sleeve. The sleeve which surrounds the side regions is understood to inherently hold the underlying bumps relatively fixed at least in that it prevents them from separating, until the force from the patient growth, and/or dilation force is applied.
Madjarov and Carpentier are involved in the same field of endeavor, namely annuloplasty rings. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the ring/system of Madjarov by having the ratchet mechanism include engaging undulating bumps and surrounding compression sleeve as is taught by Carpentier since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by Madjarov. The inclusion of the sleeve is likewise obvious in order to ensure both the ability for the sheaths surrounding the ring to be suture-permeable and allow securement to an annulus but also to prevent blood from entering into interdigitating spaces and thus preventing stagnation and clot formation, so increasing patient safety.
Regarding claims 19-20 the Madjarov Carpentier Combination teaches the ring/system of claim 11 substantially as is claimed,
wherein Madjarov further discloses the delivery system further includes an access sheath through which the adjustment filaments pass proximally, the access sheath and adjustment filaments having sufficient lengths to extend out of the body, each of the adjustment filaments passing separately through a tension adjuster (a rotating dial to adjust the tension on the associated adjustment filaments, and a gauge calibrated to indicate distance that the associated adjustment filament is displaced (see Claim Interpretation above)) to enable separate displacement of the adjustment filaments relative to the ring (claim 11 does not positively claim the “delivery system”, meaning all parts of the delivery system discussed herein as also not positively claimed).
Regarding claim 21 the Madjarov Carpentier Combination teaches the ring/system of claim 11 substantially as is claimed,
wherein Madjarov further discloses a hemostatic valve positioned at a proximal end of the access sheath, the delivery system also comprising a purse-string suture adapted to seal an access incision into a left atrium around the access sheath (claim 11 does not positively claim the “delivery system”, meaning all parts of the delivery system discussed herein as also not positively claimed).).
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madjarov and Carpentier as is applied above in view of Cartledge et al. (WO 2006105084 A2) hereinafter known as Cartledge.
Regarding claim 12 the Madjarov Carpentier Combination teaches the ring/system of claim 11 substantially as is claimed,
wherein Madjarov further discloses the passages are formed in the anterior segment (Figure 4 item 130; page 7 lines 28-30) and open to an entry hole (Figure 10a item 390) of a midsection thereof, the passages being configured such that the adjustment filaments diverge from the entry hole and emerge on a radially outward side of the midsection (Figure 10a),
wherein secondary passages are formed in the anterior segment such that the adjustment filaments extend into inner channels formed by side segments of the anterior segment (Figure 10a shows how the filaments 380, 385 are located within secondary passages adjacent anterior segment 130 which; they are considered to extend towards side segments since they connect to the ends of the posterior segment (page 19 lines 1-2)),
wherein free ends of the posterior segment overlap the anterior segment in the inner channels (Figures 5a and 10), and
the adjustment filaments attach to the free ends of the posterior segment (page 19 lines 1-2),
but is silent with regards to there being two spaced apart entry holes as opposed to one entry hole,
and silent with regards to the hole(s) being on the atrial side.
However, regarding claim 12 Cartledge teaches adjustable annuloplasty rings where adjustment filaments (Figures 40-49 items 1111, 1112) exit the ring at two spaced apart locations (Figures 40-49). Madjarov and Cartledge are involved in the same field of endeavor, namely annuloplasty rings. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the ring/system of the Madjarov Carpentier Combination so that the filaments exit the ring at two closely-spaced locations as is taught by Cartledge in order to ensure the filaments do not tangle together, which may cause device malfunction, and/or to ensure the filaments do not rub against one another, since friction might negatively affect performance and durability of the filaments. Further, while Cartledge is silent with regards to how many holes are present within the ring to accommodate the exiting of the adjustment filaments 1111, 1112, the person of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the ring/system of the Madjarov Carpentier Cartledge Combination so that there are two spaced spart holes for the adjustment filaments in order to ensure the openings stay fluid-free, as is described by Madjarov as being desirable (page 18 lines 12-15). If the filaments are spaced as is described in Cartledge, one port may not be sufficient to ensure the inside stays fluid-free.
Further, regarding claim 12 it would have been obvious to one of ordinary skill at the time the invention was filed to modify the ring/system of the Combination so that the hole(s) is/are on the atrial side since Madjarov teaches that the filaments extend through the vasculature and out of the patient’s neck (page 19 lines 15-16). Since the device is for fixing the mitral valve (abstract), the filaments must extend upwards (e.g. towards the atrial side of the mitral valve) in order to reach the neck, and so an opening on the atrial side is considered obvious.
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madjarov, Carpentier, and Cartledge as is applied above, further in view of Ortiz (US 7766815 B2).
Regarding claim 13 the Madjarov Carpentier Cartledge Combination teaches the ring/system of claim 12 substantially as is claimed,
but is silent with regards to a biasing spring positioned within the inner channels that applies a compressive force to both segments tending to force them apart.
However, regarding claim 13 Ortiz teaches an adjustable ring (Figure 4) which includes a biasing spring (Figure 4 item 322’) within an inner channel that applies a compressive force to its two ends tending to force them apart (Column 7 lines 51-57). Madjarov and Ortiz are involved in the same field of endeavor, namely adjustable, implantable rings. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the ring/system of the Combination so that there is a spring within the inner channels applying a compressive force to the segments as is taught by Ortiz in order to ensure the ring of the Combination stays at its maximal diameter until it is properly positioned, and reduction in size of the annulus via the ratchet mechanism is desired. The Examiner notes further that since the ring of the Combination includes two engagement locations of the two segments of the ring, and two locations where they expand/contract via two ratchet mechanisms, the person of ordinary skill would understand to position a biasing spring within each channel in order to apply the force evenly within the ring, ensuring even expansion/compression.
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.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 06/08/26
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