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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, species A, claims 1-15, in the reply filed on 6/15/2026 is acknowledged.
Claims 16-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Inventions II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/15/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/13/2024 and 1/15/2025 were received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Currently, no claims limitations are interpreted as invoking a 35 USC 112(f) interpretation.
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.
Claim 11 is 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. Claim 11 recites the limitation “the elongated shaft has a flexibility and the swab body has a flexibility so that, when used to collect a biological sample from a mucous membrane, the sample collection swab can collect mucus without significant physical removal of mucosal cells from the mucous membrane” which is not described in the specification and original disclosure to provide sufficient evidence to show that the applicant has possession of the claimed invention at the time of filing. Specifically, there are a multitude of parameters that go into determining flexibility of both the elongated shaft and swab body that are not described/disclosed so as to show that the applicant had possession of the full scope of the instant functional limitations. Said another way, variables that factor into the functional recitation “the elongated shaft has a flexibility and the swab body has a flexibility so that, when used to collect a biological sample from a mucous membrane, the sample collection swab can collect mucus without significant physical removal of mucosal cells from the mucous membrane” include but are not limited to material of the shaft and swab body, thickness of the elongate shaft and swab body, adhesive/mechanical connection between the elongate shaft and the swab body, and shape of the shaft and swab body. While the applicant does provide descriptions of some of these variables, the specification does not describe in sufficient detail the full scope of the claimed functional limitation of the claim. See MPEP 2163. I. A.
The lack of written description for the functional limitation is further elucidated in the 35 USC 112(b) rejection provided below showing that the scope of the claim is indefinite. The examiner encourages the applicant to amend the claim to positively recite the structural properties of the claimed elements that provide such a function in order to overcome the instant rejection.
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.
Claim 11 is 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.
The term “significant” in claim 11 is a relative term which renders the claim indefinite. The term “significant” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, the claims recitation that the flexibility of the swab and elongated shaft that the swab can collect mucus without significant physical removal of mucosal cells from the mucous membrane is indefinite as the metes and bounds of what is considered “significant physical removal” is unclear in view of the specification and drawings, and are not be reasonably appraised to one of ordinary skill in the art (essentially, the question that arises is at what point is the removal of mucosal cells considered significant”). Further adding to the confusion as to the scope of the claim, the claim recites that “the sample collection swab can collect mucus without significant physical removal of mucosal cells from the mucus membrane”, which is attempting to define the device by what its capable of doing based on who is using it. As such, it is unclear as to what is required from the actual structure of the swab body and elongated shaft to meet the limitations of the claims. Accordingly, the claim is indefinite in view of the applicant’s disclosure.
In order to advance prosecution and examine the claim on the basis of prior art to practice compact prosecution, the examiner will interpret claim 11 as any prior art structure that meets the limitations of claim 1 as providing the claimed function. As noted above, the examiner encourages the applicant to amend the claim to positively recite the structural elements of the claims that provide said functional recitation in order to overcome the instant rejection.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-4 and 7-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fong et al (US 2023/0135500 A1).
Regarding claims 1-4 and 7-15; Fong discloses a sample collection swab (element 100) for collecting a biological sample (abstract), comprising:
an elongated shaft (element 110) extending from a first end (distal end where collection elements 120 and 130 are located) to a second end (proximal end located with element 140) along a longitudinal axis, wherein the elongate shaft is comprised of a flexible polymer (paragraph [0034]-[0036]; figure 1); and
a swab body (combined elements 120 and 130) disposed at the first end of the elongated shaft (elements 120 and 130 located at first end, figure 1), wherein the swab body is comprised of a flexible elastomer (paragraph [0038]) and includes a plurality of flexible protrusions extending laterally relative to the longitudinal axis and spaces between adjacent protrusions for collecting a biological sample (paragraphs [0037]-[0040]; figures 1-5);
wherein the swab body is more flexible than the elongated shaft (wherein it discloses the elongate shaft, element 110, is more rigid than the flexible collection elements 120 and 130; paragraph [0035]).
Further regarding claims 2 and 3; Fong discloses the elongated shaft comprises a polyolefin , wherein polyolefin is selected from polypropylene and polyethylene (wherein the shaft may be polypropylene; paragraph [0036]).
Further regarding claim 4; Fong discloses the elongated shaft has a thickness that decreases from the second end toward the first end (see figure 1 wherein diameter of the elongated shaft, element 110, at section 140 is greater than diameter distal to 140).
Further regarding claims 7, 8 and 9; Fong discloses the swab body is comprised of a thermoplastic elastomer.
Further regarding claims 8 and 9; Fong discloses the thermoplastic elastomer is selected from thermoplastic vulcanizate (TPV) and thermoplastic polyurethane (TPU) (wherein the collection elements 120 and 130 can be TPU; paragraphs [0038] and [0040]).
Further regarding claim 9; The examiner notes that the limitations of claim 9 are not required in order for Fong to meet the broadest reasonable interpretation of the claim since claim 8 presents TPV and TPU in the alternative (i.e. the thermoplastic elastomer is selection from TPV and TPU). Therefore, since Fong discloses the material in the rejection of claim 8 as TPU, then it also meets the BRI of claim 9. The examiner encourages the applicant to amend the claim to positively recite that TPV is the material selected in claim 9 to avoid such an interpretation (e.g. The samples collection swab of claim 8, wherein the thermoplastic elastomer is TPV, the TPV consisting essentially of cured ethylene propylene diene monomer (EPDM) rubber particles encapsulated in a polypropylene (PP) matrix).
Further regarding claim 10; Fong discloses the swab body comprises a base (element 120) having an encircling perimeter face extending between a first end and an opposing second end, the first end terminating at a proximal face (proximal most point on element 120) that is coupled with the first end of the elongated shaft and the second end terminating at a distal face (element 130), the encircling perimeter face comprising opposing first and second side faces (wherein the examiner notes that any of the embodiments of the collection elements 200, 300, 400 and 500 can have a line drawn down the middle to segment it into two opposing faces) and opposing first and second end faces (opposing sides of a divided element 200, 300, 400 and 500) that each extend between the first end and the opposing second end of the base (see figures 2-5), wherein the plurality of flexible protrusions outwardly project from the first and second side faces (paragraphs [0037]-[0040] and [0043]-[0059]; figures 1-5).
Further regarding claim 11; Fong discloses the elongated shaft has a flexibility and the swab body has a flexibility so that, when used to collect a biological sample from a mucous membrane, the sample collection swab can collect mucus without significant physical removal of mucosal cells from the mucous membrane (wherein as noted in the 112(b) rejection above, Fong discloses the same structure as recited in claim 1, and is capable of carrying out the function as recited in claim 11).
Further regarding claims 12-15; Fong discloses a connection portion (element 140) at the second end of the elongated shaft, wherein the connection portion is configured to associate with a handle, wherein the connection portion defines a shape complementary to a shape of an attachment portion of the handle (see figure 1). The examiner notes that the limitations of the connection portion as currently recited are purely functional (wherein the limitation describe what the connection portion is configured to do) and the claim does not positively recite a handle having an attachment portion. Furthermore, the claims do not positively recite any further details of the structure of the connection portion or what the details of the shape of an attachment portion of the handle. As such, as long as the structure of the prior art is capable of carrying out the recited function, the prior art meets the broadest reasonable interpretation of the handle, see MPEP 2114. In this case, the examiner contends that Fong discloses a connection portion (the proximal portion, element 140, of the elongate shaft) which is capable of being connected to a handle having a complimentary shape (such as a collet, friction fit receiving hole, or similar attaching structure).
Further regarding claims 13-15; the limitations further define the structure of the handle which is not positively recited and do not affect the positively recited elements of the positively recited elongate shaft of claim 12, and thus do not carry patentable weight, at least as currently recited. Said another way, as long as Fong is capable of being used with a with a handle having the limitations as recited in claims 13-15, then it meets the broadest reasonable interpretation of the claims. In the instant case the examiner contends that Fong’s swab is capable of being used with handle as recited in claims 13-15. The examiner encourages the applicant to positively recite the handle (i.e. the sample collection swab of claim 1, further comprising a handle; wherein…” or similar) to overcome the current interpretation and rejection.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Fong as applied to claim 1 above, and further in view of Ching et al (US 2017/0065261 A1).
Regarding claim 5; Fong is described in the rejection of claim 1 above. Fong further discloses that the collection element 120 and 130 a disposed on the distal end of the elongate shaft (see figure 1).
However, Fong does not explicitly disclose the first end of the elongated shaft includes an enlarged connecting portion, and wherein the swab body is molded over the enlarged connecting portion.
Ching teaches a similar specimen collection swab having an elongated shaft and a swab body, wherein the first end of the elongated shaft includes an enlarged portion, and wherein the swab body is molded (paragraph [0052] discloses the device element can be molded) over the enlarged connecting portion (wherein the see figures 1-4c) in order to make the collection portion detachable (paragraph [0057]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Fong to include an enlarged connecting portion on the first end of the elongated shaft with the swab body molded over the enlarged collecting portion as taught by Ching in order to form a strong connection and/or allow for the collection portion to be detachable.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fong as applied to claim 1 above, and further in view of Voit et al (WO 2022/072666 A1).
Regarding claim 6; Fong is described in the rejection of claim 1 above, however it does not explicitly disclose the flexible polymer of the elongated shaft has a Shore A scale hardness in a range of about 50 to about 90, and wherein the flexible elastomer of the swab body has a Shore A scale hardness in a range of about 10 to about 70.
Voit teaches a nasopharyngeal swab made of a polymer rubber material wherein collection head of the swab has a Shore A hardness of less than 100 (paragraph [0051]) and the swab body can be made of a rubber with Shore A hardness of greater than 75 or 88 (paragraphs [0027]-[0028]).
Fong discloses making their nasopharyngeal swab from polymeric and elastomeric materials (paragraphs [0036],[0038] and [0040]) but is explicitly silent to the hardness of the material. Voit teaches known hardnesses for making nasopharyngeal swabs wherein the head has a Shore A hardness of less than 100 and a more rigid body of a Shore A hardness of greater than 75 or 88 (paragraphs [0027], [0028] and [0051]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to make the hardness of the elongated body of Fong’s swab to have a Shore A hardness of greater than 75 or 88 and the collection head with a Shore A hardness of less than 100 as taught by Voit in order to avoid discomfort for the user when sampling (paragraphs [0006] and [0050]).
Further regarding claim 6, the Fong/Voit combination discloses a swab wherein the flexible polymer of the elongate shaft having a Shore A hardness of greater than 75 and a flexible elastomer of the swab body with a Shore A hardness of less than 100. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Shore A hardness of the elongated shaft to be in the range of about 50 to about 90 and the swab body to have a Shore A hardness in the range of about 10 to about 70 since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facia case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Furthermore, the Fong/Voit combination as described above identifies Shore A hardness as a result effective variable affecting the comfort of the use of the swab. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select the Shore A hardness of the elongated shaft to be in the range of about 50 to about 90 and the Shore A hardness of the swab body to be in the range of about 10 to about 70 as a matter of routine optimization of a result effective variable (see MPEP 2144.05, II).
In the alternative, Fong discloses a plurality of materials that the elongated shaft and the collection head could be made out of, but is silent to the Shore A hardness of said materials. It would have been obvious to one of ordinary skill in the art at the time of filing to select from the known materials and their corresponding Shore A hardness as the selection of a known material based on its suitability for its intended use supports a prima facia case of obviousness (see MPEP 2144.07). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select a material with a Shore A hardness of the flexible polymer of the elongate shaft in a range of about 50 to about 90 and the material of the flexible elastomer of the swab body with a Shore A hardness in a range of about 10 to about 70 as selected from known materials for their intended use as a prima facie case of obviousness.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2023/0329682 A1 to Goh et al; discloses a sample collection stick.
US 2023/0329681 A1 to Goh et al; discloses a sample collection stick.
US 2023/0404545 A1 to Browka et al; discloses a specimen collection device and method.
US 2021/0321991 A1 to Elliot et al; discloses a collection swab.
US 4,718,889 to Blasius, Jr. et al; discloses an applicator swab having a cushioning element on the elongate shaft having a Shore A hardness of between 5 to 70.
WO 2015/052607 to Triva; discloses a swab for collecting samples of biological material.
KR 10-2339993 B1 to Ko et al; discloses a stick for sampling a specimen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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, Jacqueline Cheng can be reached at 571-272-5596. 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 EISEMAN/ Primary Examiner, Art Unit 3791
Prosecution Insights