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 .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 12/03/2025. Claims 5-6 and 8 are amended. Claims 1-9 are currently pending.
The rejection of claims 6 and 8 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
The rejection of claim 5 under 35 U.S.C. 112(b) has been maintained; see below.
Response to Arguments
Applicant’s arguments, see Remarks, filed 12/03/2025, with respect to the rejection(s) of claim(s) 1, 4-5, 7 and 9 under 35 U.S.C. 102(a)(1) as being anticipated by Lojewski; claim 2 under 35 U.S.C. 103 as being unpatentable over Lojewski in view of Arrowood; claim 3 under 35 U.S.C. 103 as being unpatentable over Lojewski in view of Nipper; claim 6 under 35 U.S.C. 103 as being unpatentable over Lojewski in view of Fortson; and claim 8 under 35 U.S.C. 103 as being unpatentable over Lojewski in view of Nipper and Haeussinger, have been fully considered but are not persuasive.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Applicant argues the claims should be allowable (Remarks, pg. 4). As discussed above, applicant has not specifically pointed out the novelty of the invention in view of the state of the art, or how the amendments avoid the rejections/objections in the non-final rejection mailed 06/03/2025. Accordingly, the rejection is maintained.
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.
Claim 5 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.
Regarding claim 5, the claim recites “the method as in claim 5” in the preamble. It is unclear what subject matter the claim further limits, since a claim cannot be dependent on itself. Therefore, the scope of the claim is indefinite. For examination purposes, the claim is interpreted to be dependent on claim 4, which introduces a base section.
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.
Claim 5 is 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.
Regarding claim 5, the preamble of the claim recites “the method as in claim 5”. A claim cannot be dependent on itself, therefore the claim is in improper dependent form and does not further limit the subject matter of a previously set forth claim.
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
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.
Claim(s) 1, 4-5, 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lojewski (US 2004/0092999 B1) (all references previously of record).
Regarding claim 1, Lojewski discloses (see abstract; paras. [0018]-[0037]; figs. 1-7) a method for applying pressure to a wound so as to achieve hemostasis (abstract, para. [0001]), said method comprising the steps of:
A. placing a gauze (42, para. [0033]; fig. 6) over said wound (placed over puncture site 40),
B. placing a dome (pressure applicator 14, para. [0019]) comprising a rounded top (depicted in fig. 2) on top of said gauze (fig. 6) so that said rounded top is adjacent to said gauze and is over said wound (fig. 6), and
C. placing a bandage (12, para. [0019]) over said dome (figs. 5-6) so that pressure is applied downward onto said wound (paras. [0032]-[0033]).
Regarding claim 4, Lojewski discloses the method of claim 1. Lojewski further discloses wherein said dome comprises:
A. a dome section (36, para. [0022]), and
B. a base section (34, para. [0022]) rigidly attached to said dome section (considered to be rigidly attached since Lojewski discloses pressure applicator 14 generally made of a more rigid material, para. [0022]).
Regarding claim 5, Lojewski discloses the method of claim 4 (see 112(b) rejection above). Lojewski further discloses wherein said base section (flat connecting surface 34, para. [0022]; fig. 2) is connected to said bandage via adhesive (38, para. [0023]; fig. 2).
Regarding claim 7, Lojewski discloses the method of claim 1. Lojewski further discloses wherein said wound is a needle prick (paras. [0032]-[0033]).
Regarding claim 9, Lojewski discloses (see abstract; paras. [0018]-[0037]; figs. 1-7) a method for applying pressure to a needle prick so as to achieve hemostasis (abstract, para. [0001]), said method comprising the steps of:
A. placing a gauze (42, para. [0033]; fig. 6) over said needle prick (placed over puncture site 40),
B. placing a dome (pressure applicator 14, para. [0019]) comprising a rounded top (depicted in fig. 2) on top of said gauze (fig. 6) so that said rounded top is adjacent to said gauze and is over said needle prick (fig. 6), and
C. placing a bandage (12, para. [0019]) over said dome (figs. 5-6) so that pressure is applied downward onto said needle prick (paras. [0032]-[0033]).
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.
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(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lojewski in view of Arrowood (US 5601597).
Regarding claim 2, Lojewski discloses the method of claim 1.
However, Lojewski fails to disclose wherein said dome is fabricated from non-toxic hard plastic.
Note Lojewski does disclose pressure applicator 14 generally made of a more rigid material (para. [0022]).
Arrowood teaches (col. 4 lines 3-18), in the same field of endeavor, a method for applying pressure to a wound (abstract) comprising a dome (32) formed from non-toxic hard plastic (col. 4 lines 3-18, considered to be non-toxic since the device is for use against the skin), for the purpose of forming the pressure pad of an adequate material for occluding blood flow while avoiding pinching or cutting the skin (col. 4 lines 3-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the dome of non-toxic hard plastic, in order to form the dome of an adequate material for occluding blood flow while avoiding pinching or cutting the skin, based on the teachings of Arrowood (col. 4 lines 3-18).
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lojewski in view of Nipper (US 4997438).
Regarding claim 3, Lojewski discloses the method of claim 1.
However, Lojewski fails to disclose wherein said dome is fabricated from non-toxic flexible plastic.
Note Lojewski does disclose the pressure applicator constructed of a relatively soft material (para. [0022]).
Nipper teaches (col. 2 line 66-col. 3 line 4), in the same field of endeavor, a method for applying pressure to a wound (abstract) comprising a dome (14) fabricated from non-toxic flexible plastic (considered to be non-toxic due to use on a patient’s skin, col. 2 line 66-col. 3 line 4), for the purpose of forming the cup element of an adequate material that is generally soft for applying pressure to a wound (col. 2 line 66-col. 3 line 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dome of Lojewski to be formed of non-toxic flexible plastic, in order to form the dome of an appropriate material that allows for applying adequate pressure to a wound, based on the teachings of Nipper (col. 2 line 66-col. 3 line 4).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lojewski in view of Fortson (US 2015/0327870 A1).
Regarding claim 6, Lojewski discloses the method of claim 1.
However, Lojewski fails to disclose wherein said gauze, said bandage and said dome are housed within a sterile kit.
Fortson teaches (para. [0040]), in the same field of endeavor, a method for applying pressure to a wound (abstract) comprising a sterilized kit, for the purpose of providing the system within a single package (para. [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lojewski to include packaging the gauze, bandage and dome within a sterilized kit, in order to provide the components within a single sterilized package, ready for use when desired, based on the teachings of Fortson (para. [0040]).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lojewski in view of Nipper as applied to claim 3 above, and further in view of Haeussinger (US 2017/0196569 A1).
Regarding claim 8, Lojewski (as modified) teaches the method of claim 3.
However, Lojewski (as modified) fails to teach wherein said dome further comprises a keychain hole for connection to a keychain.
Haeussinger teaches (para. [0068]; figs. 3-7), in the same field of endeavor, a method for applying pressure to a wound (abstract) comprising a dome (40, fig. 3) further comprising a keychain hole (38) for connection to a keychain (functions as a lanyard orifice), for the purpose of threading the separate parts on the lanyard to keep them together but easily accessible (para. [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dome of Lojewski (as modified) to include a keychain hole, for the purpose of providing the capability of threading the pressure applicator 14 onto a device such as a lanyard to allow for accessibility to the pressure applicator or other components of the device of Lojewski (as modified), based on the teachings of Haeussinger (para. [0063]).
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 BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIGID K BYRD/Examiner, Art Unit 3771