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 .
Drawings
The drawings are objected to because of the following.
instant application Paragraph 0037 states Figure 20 is a cross-section of Figure 19 along line C-C; however, the cross-section in Figure 20 does not line up with line C-C in Figure 19
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.
Election/Restrictions
Applicant’s election without traverse of Invention I and Species I in the reply filed on 07/21/2026 is acknowledged.
Claims 5-8 & 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/21/2026.
Applicant agreed to withdrawing Claim 13-20. Claims 5-8 & 12 are withdrawn for the reasons stated below.
As to Claim 5, the claim requires a feedback indicator to indicate to a user when a maximum force has been reached. None of Figures 1-9, which embodies elected Species I, provide any structure which one of ordinary skill in the art would determine is capable of providing the claimed indication. Figures 10-12, which embody unelected Species II-IV, each describe a respective feedback indicator –detents 150/151, magnets 144/145, and features 160/161, respectively. As such, Claim 5 requires features which are unique to an unelected species, and the claim should be withdrawn. Claims 6-8 depend on Claim 5, so should also be withdrawn.
As to Claim 12, the claim requires a free end of the raised portion extend beyond the applicator tip. Whereas sidewall 129 may be broadly interpreted as a raised portion to broadly meet the structure claimed in Claim 11, none of Figures 1-9 show sidewall 129 extending beyond applicator tip 130. However, Figure 14, which embodies unelected Species V, shows raised portions 260 extending beyond application tip 130. As such, Claim 12 requires features which are unique to an unelected species, and the claim should be withdrawn.
Claim Objections
Claims 3-4 are objected to because of the following informalities.
Claim 3 should read --The handheld device of claim 2, wherein the handheld device is capable of delivering the cosmetic substance to a depth of between approximately 10 μm and 45 μm into the epidermal layer.--, where a space should be between each value and the unit (μm)
Claim 4 should read --The handheld device of claim 1, wherein the main head body has a recess for receiving the applicator tip, and a stem which fits into a central aperture of the elongated portion.--; where a comma is placed after the term “tip”
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 as follows.
“biasing mechanism” in Claim 1, where the generic placeholder is “mechanism”, the functional language is “biasing”, and sufficient modifying language has not been provided; instant application Paragraph 0055 describes the biasing mechanism as a spring, providing sufficient modifying structure
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 § 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 10-11 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to Claim 10, the limitation “a second pressure less than or equal to a predetermined maximum force is applied to the skin” is indefinite. It is not clear how to compare the value of a pressure to the value of a force, since the units for pressure –(m*a)/A-- are different for the units of a force --m*A—rendering the claim indefinite. For the purpose of examination, any pressure value may be broadly interpreted to be less than or equal to a value of the predetermined maximum force by merely changing the units of the either of the claimed variables. For example, changing the area units from meters to centimeters would reduce the value of the pressure.
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.
Claims 1-4 & 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moeckly (U.S. PGPub 2020/0289808).
As to Claim 1, Moeckly teaches a handheld device (100) for applying a cosmetic substance (active agent on microneedle 142; Paragraphs 0092/0110) to skin (Paragraph 0092), the handheld device (100) comprising:
an elongated portion (104) capable of being grasped by a user (Paragraph 0093);
a main head body (at least 106/172/174/210) comprising a biasing mechanism (210) and being operably coupled with (as shown in Figures 14-20) the elongated portion (104), the main head body (at least 106/172/174/210) further comprising a top side (the bottom of 172, as viewed in Figure 14); and
an applicator tip (200) capable of being seated on (as shown in Figure 17; Paragraph 0165) the top side (the bottom of 172, as viewed in Figure 14) of the main head body (at least 106/172/174210) and further capable of supporting (Paragraph 0110) the cosmetic substance (active agent on microneedle 142; Paragraphs 0092/0110) to be applied to the skin (Paragraph 0092).
As to Claim 2, Moeckly teaches all the limitations of Claim 1, and continues to teach the biasing mechanism (210) of the main head body (at least 106/172/174/200/210) is operable to restrict infiltration of (as shown in Figure 18, where 142 is within lower portion 122, preventing infiltration into the skin) the cosmetic substance (active agent; Paragraph 0092) into an epidermal layer (one of ordinary skill in the art would broadly conclude microneedle penetration into the skin –Paragraphs 0138-0141—inherently results in penetrating into an epidermal layer of the skin; see Paragraph 0091) of the skin (Paragraph 0166) until a predetermined threshold force (the force required to move from Figure 18 to Figures 19/20) is applied to the applicator tip (200).
As to Claim 3, Moeckly teaches all the limitations of Claims 1-2, and continues to teach the handheld device (100) is capable of delivering the cosmetic substance (active agent; Paragraph 0092) to a depth of between approximately 10μm and 45μm into (Paragraphs 0138-0141) the epidermal layer (one of ordinary skill in the art would broadly conclude microneedle penetration into the skin –Paragraphs 0138-0141—inherently results in penetrating into an epidermal layer of the skin). Moeckly Paragraphs 0138-0141 describes active agent/microneedle 142 as being capable of penetrating the skin to a depth of 50 μm to 800 μm. One of ordinary skill in the art would conclude if a microneedle is capable of penetrating the skin to a depth of 50 μm to 800 μm, the same microneedle is capable of penetrating the skin to a depth of 10 μm to 45 μm, since 10 μm to 45 μm is less than 50 μm to 800 μm.
As to Claim 4, Moeckly teaches all the limitations of Claim 1, and continues to teach the main head body (at least 106/172/174/210) has a recess (the recess in 172 with tabs 192) for receiving (as shown in Figure 17; Paragraph 0165) the applicator tip (200) and a stem (118; see Paragraph 0095 where 106 is comprised of 118) which fits into (as shown in Figure 14) a central aperture (the bore longitudinally through 110) of the elongated portion (104).
As to Claim 10, Moeckly teaches all the limitations of Claim 1, and continues to teach the handheld device (100) is capable of delivering the cosmetic substance (active agent; Paragraph 0092) through depressing (as shown from Figure 18 to Figures 19/20, via depression of elongated portion 104, as described in Paragraph 0163) the applicator tip (200) against the skin (Paragraph 0166) with a first pressure (a first pressure required to force applicator tip 200 onto the skin, as described in Paragraph 0166) greater than (one of ordinary skill in the art would conclude the force required to overcome the spring force is greater than the spring force) a threshold minimum pressure (the spring force of biasing mechanism 210) until a second pressure (a second pressure required to force applicator tip 200 onto the skin, as described in Paragraph 0166) less than or equal to a predetermined maximum force (a maximum force applied by the user and biasing mechanism 210) is applied to the skin, wherein the handheld device (100) is capable of being held by a user (Paragraph 0093) applying pressure (Paragraph 0163).
As to Claim 11, Moeckly teaches all the limitations of Claims 1 & 10, and continues to teach a raised portion (122; see Paragraph 0095 where 106 is comprised of 122) of the main head body (at least 106/172/174/210), the raised portion (122) encircling (as shown in Figure 18) at least a portion of the applicator tip (200).
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Moeckly, in view of Gu (U.S. PGPub 2021/0145984).
As to Claim 9, Moeckly teaches all the limitations of Claim 1, and continues to teach the cosmetic substance can be made from a variety of materials (Paragraph 0110), but does not explicitly teach the cosmetic substance has a microcrystalline structure.
Gu describes microneedles for cosmetic purposes, and teaches the cosmetic substance (the microneedles described in Paragraph 0176/0177) has a microcrystalline structure (microcrystalline cellulose; Paragraph 0177).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of invention to make the cosmetic substance, as taught by Moeckly, from a microcrystalline structure, as taught by Gu, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. (1960)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Poon (2016/0271380 – see Figures 4A/4B) and Karchin (2022/0249822 – see Figures 3A/3B) teach similar devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BRANDT whose telephone number is (303)297-4776. The examiner can normally be reached Monday-Thursday 10-6, MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID N BRANDT/ Primary Examiner, Art Unit 3783
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