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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/18/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 02/18/2026 (“Amendment”). Claims 1, 3, 4, 6-12, 14, and 16 are currently under consideration. The Office acknowledges the amendments to claim 1. Claim 13 remains withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
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: “actuation member” in claims 1, 11, and 14.
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 (e.g. for “actuation member,” a spring, housing, trigger, etc., as in Fig. 2).
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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 11, there is no support for the spring being compressed before release. It is also possible for the spring to be e.g. extended before release.
Claim 12 is rejected because it depends on a rejected claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole 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. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 4, 6, 7, 10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of US Patent Application Publication 2007/0135731 (“Ward”) in view of US Patent Application Publication 2007/0232954 (“Harris”) and US Patent 3,692,020 (“Schied”).
Regarding claim 1, Ward teaches [a] skin biopsy device (Abstract, ¶ 0001) comprising: a base member configured to be placed onto a skin surface (Fig. 5, housing 14 including surface 46, ¶¶s 0027, 0031, etc.), wherein the base member comprises a jig defining a blade receiver (Fig. 5, housing 14 is a jig that receives blade 16 – see ¶ 0028); a cartridge having a blade holder and a cutting member (Fig. 5, securing member 40 and blade 16), wherein the cartridge is configured to be removably received in the blade receiver (as shown in Figs. 1 and 5 – also see ¶¶s 0028 and 0029, describing the alignment and mating via securing member 40), wherein the cutting member comprises a blade (see above) movable relative to the base member in a direction substantially orthogonal to the skin surface (¶ 0025, the aperture 38 defining the limits of movement for securing member 40, and therefore blade 16); and an actuation member (Fig. 5, handle 12) configured to drive the cutting member to travel a predetermined distance (¶¶s 0031 and 0032, the distance defined by the shape of aperture 38) at a predetermined velocity in said direction (¶ 0033 teaches a different embodiment in which the vertical movement of the blade is controlled by a spring-biased mechanism. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use this spring-biased mechanism, which limits vertical movement to a velocity defined by the spring, as the simple substitution of one known movement arrangement for another, with predictable results (predictably changing the depth of the blade), and for the purpose of minimizing the amount of user input required, thereby making the device easier to use), wherein the actuation member is separate from the base member (as shown in the exploded view of Fig. 5) and is configured to be aimed at the base member when the base member is on the skin surface (they are generally aligned during use, as shown in the figures), … and wherein the base member is configured to limit the distance travelled by the cutting member into the skin (Fig. 5, limited by the shape of aperture 38 as described in ¶ 0032) and configured to hold the cartridge in position when the actuation member is aimed at the base member (held via securing member 40).
Ward does not appear to explicitly teach wherein the base member and cartridge are each made of a transparent material.
Harris teaches making a driver and cartridge of a biopsy device out of transparent materials, to permit accurate placement of an incision (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the base member and cartridge of Ward transparent, as in Harris, for the purpose of allowing the user to accurately place the device (Harris: Abstract), and for easy viewing of the collected sample.
Ward-Harris does not appear to explicitly teach wherein the actuation member has a pistol and trigger form.
Schied teaches a rotary punch biopsy device in the form of a trigger and pistol (Figs. 1 and 2, Title, Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the handle of Ward as a trigger and pistol, like in Schied, as the simple substitution of one known actuation mechanism for another, with predictable results (performing a punch biopsy procedure), since they are known alternatives (as evinced by Ward and Schied), for the purpose of making the actuation member fast and efficient (Schied: col. 1, lines 47-61), and for making the device easier to hold and align straight with the target site.
Regarding claim 3, Ward-Harris-Schied teaches all the features with respect to claim 1, as outlined above. Ward-Harris-Schied further teaches wherein the base member has an alignment element to align the cutting member with a shape of an incision on the skin surface (Ward: ¶ 0027, teeth 48).
Regarding claim 4, Ward-Harris-Schied teaches all the features with respect to claim 1, as outlined above. Ward-Harris-Schied further teaches wherein the base member is movable relative to the skin surface, and wherein the base member is configured to generate a tension on the skin surface (Ward: ¶¶s 0027, 0031).
Regarding claims 6 and 7, Ward-Harris-Schied teaches all the features with respect to claim 1, as outlined above. Ward-Harris-Schied further teaches wherein the cutting member comprises a fusiform profile having a length to width ratio of about 3 to 1, wherein the fusiform profile comprises an apical angle of about 30 degrees (Ward: Fig. 3 shows the blade 16 as having a fusiform profile with a length to width ratio of about 3 to 1 (i.e., the length/horizontal axis is about three times longer than the width/vertical axis), and an apical angle of about 30 degrees (at the left and right sides in the figure)).
Regarding claim 10, Ward-Harris-Schied teaches all the features with respect to claim 1, as outlined above. Ward-Harris-Schied further teaches wherein the cutting member is made of stainless steel (Ward: ¶ 0028).
Regarding claim 14, Ward-Harris-Schied teaches all the features with respect to claim 1, as outlined above. Ward-Harris-Schied is not explicit that the actuation member is configured to provide a force of about 130N. However, Ward does teach use of a spring at least for longitudinal advancement of its blade, and Schied teaches using a driving spring in a rotary punch having a pistol configuration. Both of these devices use a spring to provide sufficient force to result in the longitudinal advancement of a blade into the skin, and at least Schied also provides enough force for blade rotation. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the spring of the combination to provide a force of 130N, thereby rotating and advancing the blade as in Schied, as a mere matter of design choice. Applicant’s disclosure does not describe any particular relevance of the 130N force, so it is taken to simply be a sufficient force to achieve the function. The mechanism of the combination is able to achieve this function. Therefore, it would have been obvious to choose this force to achieve the function. Further, it is submitted that the applied force is about 130N, with the term “about” not providing any particular guidance such that forces of 5N or 500N are also contemplated. And, the amount of force is a known results-effective variable because it can be changed as desired to allow sampling of different types of tissue, or with different types of blades. It would have been obvious to use a force of 130N, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ward-Harris-Schied in view of US Patent Application Publication 2018/0360481 (“Bonadio”).
Regarding claims 8 and 9, Ward-Harris-Schied teaches all the features with respect to claim 1, as outlined above. Ward-Harris-Schied does not appear to explicitly teach wherein the cutting member comprises a profile having a pair of matching zig-zag lines separated by a pre-determined gap, or wherein the cutting member comprises a profile having at least one zig-zag line, and wherein the at least one zig-zag line comprises a segment defining an obtuse angle.
Bonadio teaches a cutting element that includes a strand having a zig-zag, staggered cutting pattern of teeth (Figs. 54A-54H, ¶ 0387), with the teeth having a profile of matching zig-zag lines separated by a predetermined gap (as shown in e.g. Fig. 54F), and including a segment having an obtuse angle (as shown in Figs. 54F, 54G, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the cutting element of Bonadio at the end of the blade 16 of Ward, as the simple substitution of one known cutting arrangement (Ward: ¶ 0028, the cutting edge is described as a serrated or wave blade) for another (compare the serrations in Bonadio: Figs. 53A-53G with the zig-zag of Bonadio: Figs. 54A-54H), with predictable results (rotation would facilitate back and forth movement to cut in a saw-like manner as described in Ward: ¶ 0031 and Bonadio: ¶ 0017)).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ward-Harris-Schied in view of US Patent Application Publication 2006/0155210 (“Beckman”).
Regarding claims 11 and 12, Ward-Harris-Schied teaches all the features with respect to claim 1, as outlined above. Ward-Harris-Schied does not appear to explicitly teach wherein the actuation member comprises a spring-loaded mechanism, wherein the spring-loaded mechanism comprises a spring which is compressed before releasing the cutting member, wherein the spring-loaded mechanism comprises a dampener (although see Ward: ¶ 0033).
Beckman teaches using a compression spring in a biopsy instrument (¶¶s 0016, 0027, 0055, etc.), as well as a dampener to absorb the energy released by a spring, and to reduce impact sound (¶¶s 0027 and 0056).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a compression spring and a dampener with the spring-loaded mechanism of the combination, as in Beckman, for the purpose of storing potential energy (Beckman: ¶ 0055), for absorbing the energy released by the spring, and to reduce impact sound (Beckman: ¶¶s 0027 and 0056).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ward-Harris-Schied in view of US Patent Application Publication 2016/0354065 (“Grillo”).
Regarding claim 16, Ward-Harris-Schied teaches all the features with respect to claim 11, as outlined above. Ward-Harris-Schied does not appear to explicitly teach wherein the predetermined distance is at least 6mm.
Grillo teaches allowing a blade to travel 6mm for a cutaneous biopsy without injuring the patient (¶ 0026).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a predetermined distance of 6mm in the combination as in Grillo, for the purpose of obtaining a large sample without injuring the patient (Grillo: ¶ 0026).
Response to Arguments
Applicant’s arguments filed 02/18/2026 have been fully considered.
In response to the arguments regarding the rejections under 35 USC 112(a), they are not persuasive. The Office is not saying that the disclosure contemplates storing energy via spring extension. It is simply saying that e.g. “cocking” of a spring does not describe one of compression or extension. It could be either. And, it may be describing the one that is not claimed. I.e., support for “compression” specifically is not found. Neither is there support for “extension.” The support is only generic (e.g. for storing energy).
In response to the amendments and arguments regarding the rejections under 35 USC 103, they are persuasive to the extent that the shroud of Ward is not “configured to be removably received in the blade receiver.” Thus, a new grounds of rejection is made that recharacterizes the cartridge of Ward. Ward further teaches a separate actuation member that is aimed at the base member, as explained above. All claims remain rejected in light of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
Prosecution Insights