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 .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/24/2026 has been entered.
As filed, claims 10-12 and 23-29 are pending, wherein claims 23-29 are new; and claims 1-9 and 13-22 are cancelled.
Specification
The use of the term, “phosal 50 PG”, which is a trade name or a mark used in commerce, has been noted in this application. It should be capitalized wherever it appears and be accompanied by the generic terminology.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Response to Amendments/Remarks
Applicant’s amendments/remarks, filed 7/24/2026, with respect to claims 1 and 7-22, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below.
The § 112(a) new matter rejection of claims 16 and 21 is withdrawn per cancellation of the claims.
The § 103(a) rejection of claims 1 and 7-22 by Coulter is withdrawn per amendments and cancellation of claims 1, 7-9, and 13-22.
Claim Rejections - 35 USC § 112(a)
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.
Claims 10-12 and 23-29 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant’s amendment with respect to amended claim 10 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the limitation, “about 10% w/v to about 30% w/v”, for the instant propylene glycol concentration.
The instant specification and the originally filed claim (i.e. filed 10/21/2021) only provide support for the following w/v range for propylene glycol:
PNG
media_image1.png
310
718
media_image1.png
Greyscale
(paragraph 0036)
PNG
media_image2.png
332
724
media_image2.png
Greyscale
(paragraph 0065)
PNG
media_image3.png
144
378
media_image3.png
Greyscale
(paragraph 0117)
and thus, the word, “about”, is considered new matter; and the limitation, “about 10% w/v to about 30% w/v”, created a new subgenus for the instant propylene glycol concentration, which is also considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Applicant’s amendment with respect to amended claim 10 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the limitation, “about 5% w/v to about 15% w/v”, for the instant phosal 50 PG concentration.
The instant specification and the originally filed claim (i.e. filed 10/21/2021) only provide support for the following w/v range for phosal 50 PG:
PNG
media_image1.png
310
718
media_image1.png
Greyscale
(paragraph 0036)
PNG
media_image2.png
332
724
media_image2.png
Greyscale
(paragraph 0065)
PNG
media_image4.png
350
710
media_image4.png
Greyscale
(pg. 31, Table 1)
PNG
media_image5.png
350
708
media_image5.png
Greyscale
(pg. 33, Table 2)
PNG
media_image6.png
348
704
media_image6.png
Greyscale
(pg. 33, Table 3)
and thus, the word, “about”, is considered new matter; and the limitation, “about 5% w/v to about 15% w/v”, created a new subgenus for the instant phosal 50 PG concentration, which is also considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Applicant’s amendment with respect to amended claim 24 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the limitation, “about 20% w/v”, for the instant propylene glycol concentration.
The instant specification and the originally filed claim (i.e. filed 10/21/2021) only provide support for “at least 20% w/v” of the propylene glycol concentration:
PNG
media_image1.png
310
718
media_image1.png
Greyscale
(paragraph 0036)
PNG
media_image3.png
144
378
media_image3.png
Greyscale
(paragraph 0117)
and thus, the word, “about”, in the abovementioned limitation is considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Applicant’s amendment with respect to amended claim 25 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the limitation, “about 10% w/v”, for the instant phosal 50 PG concentration.
The instant specification and the originally filed claim (i.e. filed 10/21/2021) only provide support for “at least 10% w/v” of the phosal 50 PG concentration:
PNG
media_image1.png
310
718
media_image1.png
Greyscale
(paragraph 0036)
and thus, the word, “about”, in the abovementioned limitation is considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Regarding claims 11, 12, and 23-29, these claims are directly or indirectly dependent of claim 10, and they failed to correct the defective issue in claim 10, which rendered these claims improper.
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 10-12 and 23-29 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 claim 10, the Examiner finds “phosal 50 PG” as trademark, which is used in the claim as a limitation to identify or describe a particular material when trademark cannot be used properly to identify any particular material. Accordingly, the metes and bounds of this claim are unclear, which rendered the claim indefinite, according to MPEP 2173.05(u).
In addition, the presence of “phosal 50 PG” in the claim also constitute an improper use of the trademark.
Regarding claims 11, 12, and 23-29, these claims are directly or indirect dependent of claim 10, and they failed to correct the indefiniteness issue of claim 10, which rendered these claims indefinite.
Conclusion
Claims 10-12 and 13-29 are rejected.
Claims 1-9 and 13-22 are cancelled.
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.
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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.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
