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 .
DETAIL ACTION
This office action is a response to a 371 application filed -----5/19/2023, which is a national stage application of PCT/KR2021/016590 filed 11/15/2021, which claims foreign priority to KR10-2020-0156125 filed 11/20/2020.
As filed, claims 1-8 are pending, wherein claims 1 and 3 are independent claims.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/19/2023 has been considered by the Examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Specification
The disclosure is objected to because of the following informalities:
The amendment filed 5/19/2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “each of which is incorporated by reference herein in its entirety”.
MPEP 211.02 and MPEP 201.06(c)(IV) state the following in regard to “Incorporation by Reference” and PCT Rule 20.6, Rule 20.7 and Rule 4.18 are directed specifically to International applications:
MPEP 211.02, in-part
For applications filed on or after September 21, 2004, a claim under 35 U.S.C. 119(e) or 120 and 37 CFR 1.78 for benefit of a prior-filed provisional application, nonprovisional application, international application designating the United States, or international design application designating the United States that was present on the filing date of the continuation or divisional application, or the nonprovisional application claiming benefit of a prior-filed provisional application, is considered an incorporation by reference of the prior-filed application as to inadvertently omitted material, subject to the conditions and requirements of 37 CFR 1.57(b). The purpose of 37 CFR 1.57(b) is to provide a safeguard for applicants when all or a portion of the specification and/or drawing(s) is (are) inadvertently omitted from an application. See MPEP § 201.06 and 217. However, applicants are encouraged to provide in the specification an explicit incorporation by reference statement to the prior-filed application(s) for which benefit is claimed under 35 U.S.C. 119(e) or 120 if applicants do not wish the incorporation by reference to be limited to inadvertently omitted material pursuant to 37 CFR 1.57(b). See 37 CFR 1.57(c). See also MPEP §§ 217 and MPEP § 608.01(p).
MPEP 201.06(c)(IV), in-part
201.06(c) 37 CFR 1.53(b) and 37 CFR 1.63(d) Divisional-Continuation Procedure [R-07.2015]
IV. INCORPORATION BY REFERENCE
An applicant may incorporate by reference the prior application by including, in the continuing application-as-filed, an explicit statement that such specifically enumerated prior application or applications are “hereby incorporated by reference.” The statement must appear in the specification. See 37 CFR 1.57(c) and MPEP § 608.01(p). The inclusion of this incorporation by reference statement will permit an applicant to amend the continuing application to include subject matter from the prior application(s), without the need for a petition provided the continuing application is entitled to a filing date notwithstanding the incorporation by reference. For applications filed prior to September 21, 2004, the incorporation by reference statement may appear in the transmittal letter or in the specification. Note that for applications filed prior to September 21, 2004, if applicants used a former version of the transmittal letter form provided by the USPTO, the incorporation by reference statement could only be relied upon to add inadvertently omitted material to the continuation or divisional application.
An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a) ). If an incorporation by reference statement is included in an amendment to the specification to add a benefit claim under 35 U.S.C. 120 after the filing date of the application, the amendment would not be proper. When a benefit claim under 35 U.S.C. 120 is submitted after the filing of an application, the reference to the prior application cannot include an incorporation by reference statement of the prior application. See Dart Indus. v. Banner, 636 F.2d 684, 207 USPQ 273 (C.A.D.C. 1980).
20.6 Confirmation of Incorporation by Reference of Elements and Parts
(a) The applicant may submit to the receiving Office, within the applicable time limit under Rule 20.7, a written notice confirming that an element or part is incorporated by reference in the international application under Rule 4.18, accompanied by:
(i) a sheet or sheets embodying the entire element as contained in the earlier application or embodying the part concerned;
(ii) where the applicant has not already complied with Rule 17.1(a), (b) or (b-bis) in relation to the priority document, a copy of the earlier application as filed;
(iii) where the earlier application is not in the language in which the international application is filed, a translation of the earlier application into that language or, where a translation of the international application is required under Rule 12.3(a) or 12.4(a), a translation of the earlier application into both the language in which the international application is filed and the language of that translation; and
(iv) in the case of a part of the description, claims or drawings, an indication as to where that part is contained in the earlier application and, where applicable, in any translation referred to in item (iii).
(b) Where the receiving Office finds that the requirements of Rule 4.18 and paragraph (a) have been complied with and that the element or part referred to in paragraph (a) is completely contained in the earlier application concerned, that element or part shall be considered to have been contained in the purported international application on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(c) Where the receiving Office finds that a requirement under Rule 4.18 or paragraph (a) has not been complied with or that the element or part referred to in paragraph (a) is not completely contained in the earlier application concerned, the receiving Office shall proceed as provided for in Rule 20.3(b)(i), 20.5(b) or 20.5(c), as the case may be.
20.7 Time Limit
(a) The applicable time limit referred to in Rules 20.3(a) and (b), 20.4, 20.5(a), (b) and (c), and 20.6(a) shall be:
(i) where an invitation under Rule 20.3(a) or 20.5(a), as applicable, was sent to the applicant, two months from the date of the invitation;
(ii) where no such invitation was sent to the applicant, two months from the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office.
(b) Where neither a correction under Article 11(2) nor a notice under Rule 20.6(a) confirming the incorporation by reference of an element referred to in Article 11(1)(iii)(d) or (e) is received by the receiving Office prior to the expiration of the applicable time limit under paragraph (a), any such correction or notice received by that Office after the expiration of that time limit but before it sends a notification to the applicant under Rule 20.4(i) shall be considered to have been received within that time limit.
4.18 Statement of Incorporation by Reference
Where the international application, on the date on which one or more elements referred to in Article 11(1)(iii) were first received by the receiving Office, claims the priority of an earlier application, the request may contain a statement that, where an element of the international application referred to in Article 11(1)(iii)(d) or (e) or a part of the description, claims or drawings referred to in Rule 20.5(a) is not otherwise contained in the international application but is completely contained in the earlier application, that element or part is, subject to confirmation under Rule 20.6, incorporated by reference in the international application for the purposes of Rule 20.6. Such a statement, if not contained in the request on that date, may be added to the request if, and only if, it was otherwise contained in, or submitted with, the international application on that date.
The instant application is a 371 application which has an International filing date of 11/15/2021. See a partial capture of the BIB sheet of the instant application below.
PNG
media_image1.png
336
686
media_image1.png
Greyscale
The incorporation by reference statement is being added by way of a Preliminary Amendment filed 5/19/2023, which is after the instant application's International filing date of 11/15/2021. Therefore, the “incorporation by reference” statement being added to the instant specification by way of the Preliminary Amendment is deemed new matter.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112(b)
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 1-8 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.
Regarding claims 1 and 3, the claims recites the definition of “C0-C7 alkyl group” for instant variables R1-R4. It is unclear to the Examiner how an alkyl group can contain no carbon (i.e. C0-alkyl group) or whether C0-alkyl group pertains to a hydrogen or a bond. With such ambiguity, the metes and bounds of these claims are unclear, which rendered these claims indefinite.
For prior art purpose, the Examiner will interpret C0-alkyl group as hydrogen for instant variables R2 and R4; and a bond for instant variables R1 and R3.
Regarding claim 2, the claim is dependent of claim 1, and it failed to correct the indefiniteness issue of claim 1, which rendered the claim indefinite.
Regarding claims 4-8, the claims are directly or indirectly dependent of claim 3, and they failed to correct the indefiniteness issue of claim 3, which rendered these claims indefinite.
Claim Interpretation
With regards to the preamble phrases, such as:
“photo-cross-linking copolymerized hyaluronic acid sponge”, in claims 1 and 2; or “photo-cross-linked hyaluronic acid sponge” in claims 2-8,
they have not been accorded patentable weight for prior art purpose because such statement simply reciting the intended use for the compound of instant formula (1).
For prior art purpose, “photo-cross-linking copolymerized hyaluronic acid sponge” and “photo-cross-linked hyaluronic acid sponge” will be synonymous as composition.
Accordingly, the Examiner finds that any composition comprising prior art compound that has the same structure as the compound of instant formula (1) would be capable of performing the intended use, according to the guidance in MPEP 2111.02(II)
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.
(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, 3-5, 7, and 8 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Foreign Patent Application Publication No. WO2021/090997 and its machine-generated English translation, hereinafter Park.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Regarding claim 1, Park, for instance, teaches the following photo-crosslinked hyaluronic acid sponge comprising the following compounds 1-9.
Although the compounds of Park, as shown below, did not recite instant variables n, R3 and R4, the Examiner finds that the instant compounds are anticipated by the following compounds of Park, when variable n of Park is between 2-10000.
In addition, the Examiner, according to the guidance in MPEP 2131.02(III), also finds that a person of skill in the art, reading the disclosures of Park (as shown below), would “at once envisage” the instantly claimed arrangement or combination, which is 2-10000 for variable n of Park.
All of which meets all the limitations of the claim.
PNG
media_image2.png
356
944
media_image2.png
Greyscale
(original publication, abstract)
PNG
media_image3.png
690
1244
media_image3.png
Greyscale
(original publication, pg. 2, paragraph 20, compounds 1-6)
PNG
media_image4.png
628
1250
media_image4.png
Greyscale
(original publication, pg. 3, paragraph 21, compounds 7-9)
PNG
media_image5.png
46
348
media_image5.png
Greyscale
(machine-generated English translation , paragraph 0017)
Wherein: instant variables R1 and R3 are ranging from C0-C7 alkyl; instant variables R2 and R4 are C0 and C1 alkyl; and instant variable n is 2-10000.
Regarding claims 3-5, 7, and 8, Park, for instance, teaches the following method for preparing a photo-cross-linked hyaluronic acid sponge comprising the abovementioned compounds. All of which meet all the limitations of these claims.
PNG
media_image6.png
94
736
media_image6.png
Greyscale
PNG
media_image7.png
50
704
media_image7.png
Greyscale
PNG
media_image8.png
92
658
media_image8.png
Greyscale
(machine-generated English translation, paragraphs 0022-0024)
PNG
media_image9.png
466
798
media_image9.png
Greyscale
(original publication, paragraphs 25-26)
PNG
media_image10.png
82
706
media_image10.png
Greyscale
PNG
media_image11.png
88
720
media_image11.png
Greyscale
PNG
media_image12.png
90
740
media_image12.png
Greyscale
PNG
media_image13.png
84
674
media_image13.png
Greyscale
PNG
media_image14.png
214
672
media_image14.png
Greyscale
PNG
media_image15.png
92
700
media_image15.png
Greyscale
PNG
media_image16.png
84
722
media_image16.png
Greyscale
PNG
media_image17.png
80
692
media_image17.png
Greyscale
PNG
media_image18.png
88
718
media_image18.png
Greyscale
PNG
media_image19.png
218
700
media_image19.png
Greyscale
(machine-generated English translation, paragraphs 0031-0040)
Claim Rejections - 35 USC § 102/103
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.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1, 3-5, and 8 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over “A Swellable Microneedle Patch to Rapidly Extract Skin Interstitial Fluid for Timely Metabolic Analysis” and its supplemental information, hereinafter Chang. See IDS filed 5/19/2023.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
102(a)(1):
Regarding claim 1, Chang, for instance, teaches the following microneedle patch containing methacrylated hyaluronic acid (MeHA), which is further crosslinked through UV radiation to give crosslinked MeHA network.
Although the compounds of Park, as shown below, did not recite instant variables n, R3 and R4, the Examiner finds that the instant compounds are anticipated by the following MeHA of Chang, when variable n of Chang is between 2 or more.
In addition, the Examiner, according to the guidance in MPEP 2131.02(III), also finds that a person of skill in the art, reading the disclosures of Chang (as shown below), would “at once envisage” the instantly claimed arrangement or combination, which is 2 or more for variable n of Chang, since the MeHA of Chang is shown to be polymeric.
All of which meets all the limitations of the claim.
PNG
media_image20.png
714
990
media_image20.png
Greyscale
PNG
media_image21.png
356
518
media_image21.png
Greyscale
PNG
media_image22.png
486
1660
media_image22.png
Greyscale
(pg. 14 of the supporting information)
Regarding claims 3-5 and 8, Chang, for instance, teaches a method, comprising the steps of dissolving hyaluronic acid in water; adding a methacrylic anhydride and sodium hydroxide to the solution; immersing the solution in ethanol, and then performing lyophilization so as to prepare MeHA; adding a photo initiator, which is Irgacure 2959 (also known as 2-hydroxy-1-[4-(2-hydroxyethopxy)phenyl] 2-methyl-1-propane) and water to the MeHA; and irradiating the solution with UV rays, and performing a crosslinking reaction so as to prepare a crosslinked MeHA network in the MeHA microneedle patch.
All of which meets all the limitations of these claims.
PNG
media_image23.png
406
648
media_image23.png
Greyscale
(pg. 3 of the supporting information)
PNG
media_image24.png
448
664
media_image24.png
Greyscale
(pg. 4 of the supporting information)
However, if a person of skill in the art, reading the disclosures of Chang, would not “at once envisage” the instantly claimed arrangement or combination, which is 2 or more for variable n of Chang, the instant claimed compounds are prima facie obvious over Chang, for the following reasons:
103:
Determining the scope and contents of the prior art:
Regarding claims 1, 3-5, and 8, Chang, for instance, teaches the abovementioned MeHA/crosslinked MeHA network; and preparation method thereof.
Ascertaining of the difference between the prior art and the claim at issue:
Chang, for instance, did not explicitly teach instant variables n, R3 and R4 in the abovementioned MeHA/crosslinked MeHA network.
Finding of prima facie obviousness --- rationale and motivation:
The Examiner finds a person of ordinary skill in the art would recognize that MeHA of Chang is a polymer, wherein polymer is made from many repeating monomer linking together to form long chains. Accordingly, it would have been obvious to one of person ordinary skill in the art to recognize that variable n of Chang is 2 or more, and the instant compounds are prima facie obvious over the MeHA of Chang when variable n of Chang is 2 or more.
Claim Objections
Claims 1-4 and 6-8 are objected to because of the following informalities:
Regarding claims 1 and 3, the claims recite the phrase, “wherein, in [Formula 1] above”. Such expression can be clarified by reciting -- wherein, in [Formula 1]
Regarding claim 2, the claim recites the phrase, “wherein the compound represented by [Formula 1] is characterized in that it is a compound represented by [Formula 2] below”.
Such expression can be clarified by reciting -- wherein the compound represented by [Formula 1] is
Regarding claim 3, the claim recites the phrase, “(S1) preparing a compound represented by [Formula 1] below”.
Such expression can be clarified by reciting -- S1) preparing a compound represented by [Formula 1]
Regarding claim 4, the claim recites the phrase, “wherein the step (S1) is characterized in that it consist of”.
Such expression can be clarified by reciting -- wherein the step (S1) is
Regarding claim 6, the claim recites the phrase, “wherein the compound represented by [Formula 1] above is characterized in that it is a compound represented by [Formula 2] below”.
Such expression can be clarified by reciting -- wherein the compound represented by [Formula 1]
Regarding claim 7, the claim recites the phrase, “to the compound represented by [Formula 1] above; (S2B) irradiating”.
Such expression can be clarified by reciting -- to the compound represented by [Formula 1]
Regarding claim 8, the claim recites the phrase, “wherein the photoinitiator is characterized in that it is at least one selected from”.
Such expression can be clarified by reciting -- wherein the photoinitiator is --.
Appropriate correction is required.
Conclusion
Claims 1-8 are rejected.
Claims 1-4 and 6-8 are objected.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 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, Clinton Brooks can be reached at (571)270-7682. 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.
/PO-CHIH CHEN/Primary Examiner, Art Unit 1621