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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 C.F.R. § 1.114 (“RCE”), including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 31 July 2025 (“Reply”) has been entered.
Response to Amendment
This Action is responsive to the RCE and Reply. As directed in the Reply:
Claims 1-7, 9, 11, 13, 14, 21-23, and 25 have been amended;
Claims 8, 10, 15-20, and 24 have been and/or remain cancelled; and
Claims 26-29 have been added.
Thus, Claims 1-7, 9, 11-14, 21-23, and 25-29 are presently pending in this application.
Response to Arguments
Applicant's arguments filed in the Reply have been fully considered but they are not fully persuasive.
Applicant argues (Reply, pg. 8) that Cracauer is not read on by the pending claims, because, according to Applicant, it is not read on by the newly added clause:
wherein the pullout resistor is configured to be inserted into the body cavity in the collapsed state and to deploy from the collapsed state to the deployed state once the delivery device is passed through an incision and the pullout resistor is positioned within the body cavity.
Applicant argues (id.) that, because Cracauer may not specifically discuss the foregoing functional of use of its device, specifically the ‘collapse to insert’ manipulation, that it cannot anticipate the claims. But Applicant badly misreads the claims. A recitation of the intended or functional use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use or the function, then it meets the claim. Cracauer’s pullout resistor is clearly capable of being used in the manner required by the claim, as demonstrated by the collapsibility of the device described throughout the disclosure, and illustrated in its Fig. 4. Furthermore, the claim does not, in its intended use or functional recitation, limit in any meaningful way how, under what conditions, with what additional devices, in which body cavity, through what other body tissue, and how collapsed the pullout resistor must be to be read on by the claim, and is thus significantly broader than it appears Applicant believes. Cracauer’s pullout resistor is collapsable enough that it is read on by the claims.
Applicant’s arguments concerning the rejections under sec. 103 depend expressly from the foregoing argument, and are thus similarly unpersuasive. Lastly, Applicant neatly reproduces new Claims 26-29, but only asserts, without identifying record evidence, that they are also free of the art; they are addressed on the merits below.
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 combinations recited in kit Claims 28 and 29, originally illustrated in U.S. App. No. 62/630,525, which was properly incorporated by reference into this application, 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
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the subject matters of new Claims 28 and 29, while finding support in the provisional application, to which the instant application claims priority and which is properly incorporated by reference, do not appear in the application as filed.
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
Claim Objections
Claim 9 is objected to because of the following informalities: the Markush group is malformed because it states “or” instead of “and.” Appropriate correction is required.
Claim Interpretation
The pending claims are given their broadest reasonable interpretation consistent with the specification, as it would be interpreted by one of ordinary skill in the art. The words of the claims are given their plain the ordinary and customary meaning given to the term by those of ordinary skill in the art as of the effective filing date of the patent application, unless such meaning is inconsistent with the specification. The only exceptions to giving the words in a claim their ordinary and customary meaning in the art are: (1) when the applicant acts as their own lexicographer; and (2) when the applicant disavows or disclaims the full scope of a claim term in the specification. See M.P.E.P. § 2111.
Claim Rejections - 35 USC § 102
Claims 1-4, 21-23, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 6,039,714, granted to Cracauer et al. (“Cracauer”), with reference to the cropped, cleaned, and annotated version of its Fig. 1, below (“AnnFig”).
Cracauer describes a device as claimed by Applicant, as follows.
Claim 1: A delivery device (a gastrostomy or jejunal feeding tube delivery device, see Fig. 2, col. 3, ll. 60-63, and col. 6, ll. 1-8), comprising:
an elongated structure (24) comprising a first opening at a first end of the elongated structure (27) and a second opening at a second end of the elongated structure (25), the elongated structure defining a lumen between the first opening and the second opening for delivery of a fluid to a subject in which the elongated structure is inserted (see Fig. 2, and col. 6, ll. 1-8); and
a pullout resistor (2) configured to anchor the elongated structure (24) with an interior portion of a body cavity of the subject (the mucosal lining 32 of a stomach or the muscle fascia 30 of the abdominal wall) when the pullout resistor is in a deployed state (Fig. 3) and to collapse from the deployed state to a collapsed state when a predetermined amount of force is applied in a direction along a longitudinal axis of the elongated structure (Fig. 4; see col. 6, ll. 20-35, col. 6, ln. 48-col. 7, ln. 22),
wherein the pullout resistor is configured to be inserted into the body cavity in the collapsed state and to deploy from the collapsed state to the deployed state once the delivery device is passed through an incision and the pullout resistor is positioned within the body cavity (see discussion above; pullout resistor 2 is fully capable of performing the function of this last paragraph).
Claim 2: (The device of claim 1,) further comprising a washer (36) configured to slide along a length of the longitudinal axis of the elongated structure to clamp an abdominal wall of the subject between the washer and the pullout resistor (see Figs. 2-3, col. 6, ll. 1-4 and ll. 28-32).
Claim 3: (The device of claim 1) wherein the pullout resistor comprises a plurality of retaining members (6) projecting perpendicular to an external surface of the elongated structure (see Figs. 1-2, where the pullout resistor 2 comprises three retaining members 6 which project perpendicularly to the external surface of the elongated structure 24, col. 4, ll. 16-30).
Claim 4: (The device of claim 3,) wherein the plurality of retaining members project perpendicular to the external surface of the elongated structure in the deployed state and deflect toward the external surface of the elongated structure in the collapsed state (see Fig. 3, retaining members 6 project perpendicular to the elongated structure 24 in the first, extended state; see Fig. 4, where the retaining members 6 deflect toward the elongated structure 24 in the second state, col. 6, ll. 48-51, and col. 7, ll. 2-19).
Claim 21: (The device of claim 1,) wherein the pullout resistor comprises a plurality of retaining members (6), and a thickness of the retaining members varies between the external surface of the elongated structure to the outer periphery of the pullout resistor (because the thickness of the leaves/flanges 6 are not constant, it varies; col. 4, lines 32-34).
Claim 22: (The device of claim 1,) wherein the pullout resistor comprises a plurality of retaining members (6), and the retaining members are thinner toward the outer periphery of the pullout resistor than at inward portions of the pullout resistor (id.).
Claim 23: (The device of claim 1,) wherein the pullout resistor has a first retainer portion (AnnFig: FRP, radially between the dash-dot line and the bore 12) radially extending outwards from the external surface of the elongated structure to a second retaining portion that radially extends outwards from the first retainer portion to an outer periphery of the pullout resistor (AnnFig: SRP, radially between the two dash-dot lines, i.e., between the FRP and the outer edges of the leaves/flanges 6), and wherein the second retainer portion is thinner than the first retainer portion (col. 4, lines 32-34).
Claim 25: (The device of claim 24,) wherein the pullout resistor is circular (a circle, shown by the outer dash-dot line in AnnFig, can be circumscribed onto the outer edges of the leaves/flanges 6, and thus the pullout resistor is ‘like a circle,’ that is, circular), wherein the pullout resistor has a first retainer portion (AnnFig: FRP, radially between the dash-dot line and the bore 12) radially extending outwards from the external surface of the elongated structure to a second retaining portion that radially extends outwards from the first retainer portion to an outer periphery of the pullout resistor (AnnFig: SRP, radially between the two dash-dot lines, i.e., between the FRP and the outer edges of the leaves/flanges 6), and wherein the first retainer portion forms an inner circle of the pullout resistor (see AnnFig) and the second retainer portion forms an outer circle of the pullout resistor (id.; see also discussion concerning Claim 24).
Claim Rejections - 35 USC § 103
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Cracauer.
Cracauer discloses a device substantially as claimed by Applicant; in addition to the subject matter of Claim 1, its pullout resistor comprises a plurality of retaining members (6). It does not, however describe that: each of the plurality of retaining members has a thickness between 0.5 mm and 5 mm (Claim 5); each of the plurality of retaining members has a length between 3 mm and 15 mm (Claim 6); or, that the pullout resistor has a pullout resistor material hardness configured for the predetermined amount of force is between 5 lbs and 10 lbs (Claim 7).
A full review of Applicant’s disclosure reveals that no specific attribute or function is attributed to the dimensions of Claims 5 and 6:
The thickness of each retaining member 308 can be between about 0.5 mm and about 5 mm, between about 0.5 mm and about 4.5 mm, between about 1 mm and about 4 mm, between about 1.5 mm and about 3.5 mm, or between about 2 mm and about 3 mm. Each of the retaining members 308 can extend from the external surface 300 of the elongated structure 112 to a length 304 between about 3 mm and about 15 mm, between about 5 mm and about 15 mm, or between about 5 mm and about 15 mm. The pullout resistor 104 can have a diameter or width between about 5 mm and about 30 mm, between about 10 mm and about 30 mm, between about 10 mm and about 25 mm, or between about 15 mm and about 25 mm.
(Specification at [0040]). Because the only difference between the prior art and the claims appears to be a recitation of dimensions of the claimed device and Cracauer’s device (it’s retaining members 6 have a thickness and a radial length), and there is no evidence of record that having the claimed relative dimensions would allow Applicant’s device to perform differently than Cracauer’s device, the claimed dimensions are merely design choices. See, e.g., Gardner v. TEC Syst., Inc., 725 F.2d 1338, (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984).
It 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, to construct Cracauer’s retaining members with the dimensions of Claims 5 and 6, because there is no evidence of record that they are anything other than preferred dimensions of the members, not causing Applicant’s claimed combination to perform differently, and thus would be an obvious design choice.
Concerning Claim 7, Cracauer teaches that the predetermined amount of force is sufficient to pull the device from the patient's abdomen without injuring the ostomy tract (see col. 6, ll. 64-col. 7, ll. 22). Similar to the disclosure underlying Claims 5 and 6, Applicant’s specification describes no specific attribute or function is attributed to the range of Claim 7:
In some implementations, the force to collapse the pullout resistor 104 from the first state to the second state can be at least 3 lbs, at least 4 lbs, at least 5 lbs, at least 6 lbs, at least 7 lbs, at least 8 lbs, at least 9 lbs, at least 10 lbs, at least 11 lbs, at least 12 lbs, at least 13 lbs, at least 14 lbs, or at least 15 lbs. The force can be between about 3 lbs and about 20 lbs, between about 5 lbs and about 15 lbs, or between about 5 lbs and about 10 lbs.
(Specification at [0033]). Because Cracauer specifically describes the action of pulling out its device and the folding of its retaining members, and the force necessary to do so, Cracauer teaches that the force needed to collapse its retainers, and thus permit removal of the device, is a result-effective variable of the device’s design. Because the only difference between the prior art and the subject matter of Claim 7 appears to be a recitation of the collapse force the claimed retention members, Cracauer’s retaining members 6 have collapse force, as discussed above, and Cracauer’s discusses this being a result-effective variable of its device, a person of ordinary skill in the art finds in Cracauer a motivation to optimize that force for the exact same use, and doing so would involve no more than routine optimization of that variable. See, e.g., In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Accordingly, it 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, to construct Cracauer’s retaining members such that their collapse force is in the range of Claim 7, because there is no evidence of record that the claimed range is anything other than a preferred range, not causing Applicant’s claimed combination to perform differently, the collapse force is a result-effective variable of Cracauer’s retaining members, and thus a person of ordinary skill in the art is motivated to optimize that variable to make the device perform better.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Cracauer as applied to Claim 1 above, and further in view of U.S. Patent No. 6,464,686, granted to O’Hara et al. (“O’Hara”) and U.S. Patent No. 6,186,985, granted to Snow (“Snow”).
Cracauer discloses a device substantially as claimed; see above. It does not, however, disclose its device including a radiopaque strip extending along at least a portion of the elongated structure.
O’Hara relates to percutaneous endoscopic gastrostomy tubes and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. O’Hara teaches that such devices, like that of Cracauer, may be constructed with a radiopaque strip extending along at least a portion of the elongated structure (col. 13, lines 61-64), to allow the practitioner to see the position and rotational orientation of the feeding device in situ.
It 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, to construct Cracauer’s feeding tube with a radiopaque strip extending along at least a portion of the elongated structure, because O’Hara teaches doing so in a closely-related feeding tube, to allow the practitioner to see the position and rotational orientation of the feeding device in situ.
Cracauer discloses the device substantially as claimed, see above, but also does not explicitly teach that the elongated structure comprises an antibiotic or antimicrobial coating.
Snow relates to percutaneous gastrostomy tubes and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Snow teaches that such a feeding tube can be coated with an antibiotic to prevent infection at the stoma tract (see Fig. 1, col. 5, line 61 to col. 6, line 2, and col. 7, ll. 57-67).
It 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, to construct Cracauer’s feeding tube with an antibiotic coating, because Snow teaches doing so in a closely-related device, in order to have provided a safer delivery device that decreases the risk of infection.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Cracauer as applied to Claim 1 above, and further in view of U.S. Patent App. Publ. No. 2004/0181194, by Perkins (“Perkins”).
Cracauer identically discloses the subject matter of the first three paragraphs of Claim 11, which is the same as that recited in Claims 1 and 2 (see above); the subject matter of Claim 13, which is the same that of Claim 3 (see above); and the subject matter of Claim 14, which is the same as that of Claim 4 (see above). Cracauer does not describe the further inclusion of a brush configured to slide within the lumen of the elongated structure; or that the brush has a length less than a length of the delivery device.
Perkins relates to percutaneous endogastric tubes and their cleaning, and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Perkins teaches that such feeding tubes can be providing with a tube cleaning brush (10) designed to slide within the lumen of a feeding tube (12, see Figs. 1A and 2, and [0022]), where the brush allows a user to clean the interior of the tube and remove obstructions (id.).
It 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, to provide, with Cracauer’s feeding tube, a brush configured to slide within the lumen of the elongated structure, because Perkins teaches doing so with a closely-related feeding tube, to allow a user to clean the interior of the tube and remove obstructions. Concerning Claim 12, Perkins’ brush has “a length,” meaning any portion of its brush, e.g., of its “flexible brush filaments 36 positioned within an end segment having an axial length illustrated at 40 in FIG. 4a of about 3.0 cm” ([0026]), which is less that the length of its feeding tube as illustrated in Fig. 2, and thus is read on by Claim 12.
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Cracauer as applied to Claim 1 above, and further in view of U.S. Patent App. Pub. No. 2011/0313359, by Cohen (“Cohen”).
Cracauer discloses the device substantially as claimed, see above, but does not disclose that it is in further combination with a sheath configured to slide over the pullout resistor to collapse the pullout resistor toward the elongated structure and thereby restrain the pullout resistor in the collapsed state (Claim 26), or that the sheath is configured to be slid off the pullout resistor to deploy the pullout resistor (Claim 27).
Cohen relates to percutaneous gastrostomy tubes and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Cohen teaches (Figs. 1A-C and accompanying text) that such a feeding tube (11) can be used in combination with a sheath (13) configured to slide over the pullout resistor to collapse the pullout resistor toward the elongated structure and thereby restrain the pullout resistor in the collapsed state (compare Figs. 1A and 1B), and that the sheath is configured to be slid off the pullout resistor to deploy the pullout resistor (same), so that the practitioner can selectively collapse and deploy the retention members 20 in the patient.
It 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, to provide, with Cracauer’s feeding tube, a sheath configured to slide over the pullout resistor to collapse the pullout resistor toward the elongated structure and thereby restrain the pullout resistor in the collapsed state, and that the sheath is configured to be slid off the pullout resistor to deploy the pullout resistor, because Cohen teaches doing so in a closely related device so that the practitioner can selectively collapse and deploy the retention members in the patient.
Allowable Subject Matter
Claims 28 and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
The prior art of record, taken both alone and in permissible combination, fails to identically disclose or fairly suggest the combinations of features recited in Claim 28, taken with the features of the claim(s) from which it depends. More specifically, there is not sufficient evidence in the record to support a conclusion that it would have been obvious to modify any of the kits described in the prior art of record to include two pullout resistors, having different hardnesses, such that the two pullout resistors are configured to collapse when different predetermined amounts of force are applied in the direction along the longitudinal axis of the elongated structure.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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, Bhisma Mehta, can be reached on 571.272.3383. 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.
/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783