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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 6/22/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
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:
“brush control mechanism” in claims 12 and 23.
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.
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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 12 and 19-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Worthen et al. (US 5,445,164, hereinafter Worthen).
For claim 12, Worthen discloses an apparatus (10) for conducting gynecological and proctological exams (Figs 1-10) (Title, abstract, Cols 1-4), comprising inter alia:
a sensor body (12) having a proximal end (left end Fig 8), a distal end (right end Fig 8), a first passage (lumen of 12 in Fig 8) passing through the sensor body from the proximal end to the distal end (Fig 8), and a lip (14) disposed on the distal end of the sensor body (Fig 8);
a brush control mechanism (33) (Fig 3 and 8) having a proximal end (left end Fig 3) and a distal end (right end Fig 3), the proximal end of the brush control mechanism configured to pass through the first passage from the distal end of the sensor body (Figs 3 and 8), the brush control mechanism extending along a longitudinal control axis that is parallel to a longitudinal axis of the apparatus (Figs 3 and 8);
a brush (34, 40) disposed on the distal end of the brush control mechanism (Fig 3), the brush coupled to the brush control mechanism via a connector (38); and
a grip (16) disposed on the proximal end of the sensor body (Fig 8), the grip including a first handle (20) and a second handle (22) (Fig 8), at least one of the first handle and the second handle is disposed perpendicular to a longitudinal axis (Fig 8) of the apparatus and including a plurality of finger grooves (21,23).
For claim 19, Worthen discloses the apparatus of claim 12, wherein the sensor body further comprises an alignment guide (30, 32) (Fig 8) and the brush control mechanism further comprises an alignment protrusion (74, 76, 78, 80, 82, 84, 86, 88) (Fig 8), wherein the alignment guide of the sensor body is configured to receive the alignment protrusion of the brush control mechanism (Fig 8) and would inherently rotate the brush control mechanism.
For claim 20, Worthen discloses the apparatus of claim 19, wherein the alignment guide further includes a stop (30, 32) (Fig 8) configured to inhibit movement of the brush control mechanism (Cols 1-4).
For claim 21, Worthen discloses the apparatus of claim 12, wherein the first passage defines a first length and the brush control mechanism defines a rod having a second length, longer than the first length (Figs 1-10).
For claim 22, Worthen discloses the apparatus of claim 12, wherein the brush comprises a tissue swab (36).
Response to Arguments
Applicant's arguments filed 6/22/26 have been fully considered but they are not persuasive, wherein Applicant argues the following:
“Worthen does not disclose (1) a brush control mechanism extending along a longitudinal brush control axis that is parallel to a longitudinal axis of the apparatus; (2) a brush that is coupled to such a brush control mechanism via a connector; or (3) at least one of a first and second handle of a grip including a plurality of finger grooves.”
In response the Examiner respectfully disagrees and notes the following:
As set forth and cited hereinabove, Worthen more than fairly and reasonably discloses inter alia (1) a brush control mechanism extending along a longitudinal brush control axis that is parallel to a longitudinal axis of the apparatus; (2) a brush that is coupled to such a brush control mechanism via a connector; or (3) at least one of a first and second handle of a grip including a plurality of finger grooves.
As broadly as structurally claimed, absent any structural distinctions to the contrary, and absent any special definition in the instant Specification upon which Applicant does not appear to rely, (i) Worthen’s plunger assembly 33 may more than fairly and reasonably be considered at least “a brush control mechanism” shown in Figures 3 and 8 to extend along a longitudinal brush control axis that is parallel to a longitudinal axis of the apparatus, (ii) Worthen’s circular brush 34 and sponge 40 shown in Figures 3 and 8 may more than fairly and reasonably be considered at least a brush that is coupled to the brush control mechanism via a connector 38 as a stem portion of the stainless steel wire 36, and (iii) Worthren’s hand and finger gripping manipulable flange 16 which includes four corner-centric handles with fingers grooves interposed therebetween is perpendicular the sensor body as seen in Figures 3 and 8 and may more than fairly and reasonably be considered at least one of a first and second handle of a grip including a plurality of finger grooves.
Worthen evidentiarily demonstrates (Cols 2-3) the claimed invention and explicitly states inter alia the following (emphasis added):
“Referring now to the drawings, wherein like reference numerals designate corresponding structure throughout the views, and referring in particular to FIGS. 1, 2, and 8, the cervical tissue sampling device 10 according to a first preferred embodiment of the invention includes an elongated substantially rigid, substantially cylindrical barrel 12 possessing a circular open front end 14 and terminating at a rear open circular end 28 within a circular recess 29 in an irregularly shaped radially extending finger grip flange 16. The barrel 12 and flange 16 are preferably formed from #PE2067 low-density polyethylene, available from Branchcomb Industries, Sapulpa, Ok. As shown in FIGS. 4, 5, and 8, the finger grip flange 16 possesses convex arcuately curved corner projecting portions 20, 22, 24, and 26 spaced around the periphery of the flange 16. These corner projections are separated by respective concave arcuate recesses 21, 23, 25, and 27. As may be appreciated with reference to FIG. 2, the barrel 12 may be integrally molded with the flange 16, or alternatively may be assembled from separate components by press fitting the rear circular open end 28 of the barrel 12 into a conforming aperture formed centrally in the flange 16. Suitable adhesives may also be employed to effect securement of the flange 16 to the barrel 12. The barrel 12, as depicted in FIG. 8, possesses internal axially spaced annular ridges 30 and 32 formed internally within the barrel 12 adjacent flange 16 for the purpose of retaining a plunger assembly therein, in a manner to be described subsequently in greater detail.
“With reference to FIGS. 3 and 8, the cervical tissue sampling device 10 according to the present invention includes a plunger assembly 33 terminating at a distal end in a circular brush 34 preferably formed by twisting nylon bristles between strands of stainless steel wire 36. A suitable brush is made from type 304 stainless steel wire, 0.02 inches in diameter, mil spec MS209956, and type 612 natural level nylon, 0.005 inches in diameter, FDA# 21CFR1771-1500, and is available from Gordon Brush Company, Los Angeles, Ca. The initially straight brush is subsequently deformed into the generally circular illustrated configuration, with a stem portion 38 of the stainless steel wire 36 extending rearwardly through a central aperture of a circular sponge 40. A suitable sponge is a 2 inch diameter circle of 0.0625 inch thick open-cell cellulose sponge, #1935, with a 0.25 inch central hole, available from Lundell Manufacturing Corporation, Minneapolis, Mn. The circular brush 34 has a diameter of about 3.5 centimeters, while the surrounding sponge 40 has a diameter of about 5.0 centimeters. A typical cervix has a diameter of 5.0 to 5.5 centimeters. The stem portion 38 of the stainless steel wire 36 is press fit within a central bore 46 formed in a radially enlarged circular end flange 42 of a stem 44. The stem 44 is inserted through a sleeve 50 terminating in a second radially enlarged circular end flange 48. Accordingly, the end flange 42 forms an abutment surface for the rear face of the sponge 40 and serves to press the sponge 40 against the rear face of the circular brush 34. The flange 42 also serves as a stop restricting forward axial movement of sleeve 50 due to flange 42 having a greater outer diameter than the inner diameters of flange 48 and sleeve 50. The stem 44 terminates at an axially inward end in a semi-cylindrical connector tab end portion 52. A pin 54 extends transversely to the axis of the stem 44 from a central location on the flat interior surface of connector tab portion 52. A second sleeve 56 which includes a radially enlarged terminal circular flange 58 is dimensioned for a relatively tight fitting, sliding, frictional engagement over the stem 44 and also over a plunger shaft 64. As shown in FIG. 8, the plunger shaft 64 terminates in a second semi-cylindrical connector tab end portion 60 provided with a transversely extending aperture 62 dimensioned for frictional engagement with the pin 54 of tab end portion 52 of stem 44. Accordingly, it may now be understood that a selectively detachable connection is formed by stem 44 and plunger shaft 64, such that the stem 44 and attached brush 34 and sponge 40 may be removed as desired by sliding sleeve 56 rearwardly along shaft 64 until engaged tab end portions 52 and 60 are exposed. The pin 54 may then be manually disengaged from aperture 62, to complete detachment of stem 44 from shaft 64.”
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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 nonprovisional extension fee (37 CFR 1.17(a)) 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 Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm 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, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
Prosecution Insights