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 .
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 4, and 10 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. With regard to claim 4, the term “easily” is a relative term which renders the claim indefinite. The term “easily” 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. Although the specification refers to certain materials that the supporting part may be constructed from, these do not serve to define the relative term “easily” in a manner that the phrase “easily cut” can be readily assessed. With regard to claim 10, the phrase “the end” of the support part lacks antecedent basis.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 3, 8, and 20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claims generally indicate intended uses; however, the uses do not impose structural requirements on the positively claimed elements. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1 – 4, 8, 10, 12, 19 - 21, and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Triva (USPGPub 2014/0083213). Triva teach a collection device/swab (Figures 1, 2) including sampling, grip points, and weakened portion. Triva provide details of physical dimensions, configurations/positions, and properties of the components (as generally described on page 2 section of paragraph [0029]). Further, Triva discuss use of the collection swab as part of a testing kit and associated collection and analysis methods (as generally described on page 3, column 2 section of paragraph [0029]). Examiner notes that the extended support body permits a user to grip along its length during use, permitting one to utilize plural gripping locations dependent upon the body location they are trying to access for the sample.
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(s) 5 – 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Triva as applied to claim 1 above, further in view of Slowey et al. (USPGPub 2012/0067144). Triva teaches a collection swab as discussed above, including gripping regions. However, Triva does not specifically indicate a structure associated with the gripping portion. Slowey teach a collection arrangement (Figure 16) that incorporates ergonomic and gripping elements to provide defined positions for the user to grip the device during use. It would have been within the skill level of the art before the effective filing date of the claimed invention to have implemented the gripping portions of Triva with ergonomic/gripping structures, as taught in Slowey et al., since this provides improved/enhanced usability of the collection device.
Claim(s) 9, 11, 13, 14, 15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Triva as applied to claims 1, 8, 10, and 12 above. Triva teaches a collection swab as discussed above, including collection, gripping, and weakened portions as well as associated dimensions that the structures may cover, but Triva does not specifically indicate the relative positions/ratios between portions. However, the teaching of Triva provides evidence that these dimensions are in the category of result-effective variables, and it has generally been held to be within the skill level of the art to perform routine experimentation to optimize such variables for intended use. As such, absent a showing of unexpected results or criticality, it would have been within the skill level of the art before the effective filing date of the claimed invention to have performed routine experimentation to determine appropriate dimensions/ratios when implementing the sample collector for permitting a user of the swab device to effectively collect the samples in the intended manner. Additionally, although Triva generally shows one weakened section on their device, it has generally been held to be within the skill level of the art to provide duplicate parts, absent a new or unexpected result, such that a second/additional weakened section could be part of the support body. One could determine optimal positioning of the second weakened section relative to the first, consistent with the discussion of optimization above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Decker et al. (USPGPub 2021/0290210), Ji et al. (USPGPub 2023/0194389), Sayani et al. (USPGPub 2022/0133283), Roswech et al. (USPGPub 2021/0378643), Triva (USPGPub 2016/0367227), and Elliott et al. (USPGPub 2021/0321991) teach additional examples of collection swabs with claimed features. Further, Yardley (USPGPub 2013/0184684) teach a sampling/nasal device that incorporates gripping sections.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC FRANK WINAKUR whose telephone number is (571)272-4736. The examiner can normally be reached Mon-Fri 9 am - 6 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, Chuck 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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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791