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 Group II, claims 16 and 17, drawn to a method for promoting in the reply filed on August 4th, 2026 is acknowledged. Claims 11-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The applicant has added new claims 18-20, depending from claim 16.
Claims 16-20 are pending and were examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The priority date is December 3rd, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 2nd, 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Although the received copy of reference Cite No. A7 is partly illegible, a legible copy was accessible to the examiner over the internet.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show distinct fluorescence immunostaining for Ki-67 and MSCP as described in the specification (paragraphs [0039]-[0042]) because figures 1, 3, and 5 currently lack color. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
If the applicant chooses to file color photographs to overcome this objection, then the applicant is notified that color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The disclosure is objected to because of the following informalities: paragraph [0039] recites paraffin slices hydrated using "EtOH" (understood as ethanol). However, the term "hydrated" implies the use of water. The applicant should consider replacing the word "hydrated" with a different word to .
Appropriate correction is required.
The use of the terms VapoMeter, Ichimaru Pharcos, and Thermo Fisher Scientific, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
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.
The applicant’s assistance is requested in properly reciting any trademarks or tradenames they become aware of in the instant disclosure, even if not explicitly pointed out by the examiner.
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 16-20 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. Claim 16 recites the phrase “improving wrinkles”, but it is not clear what changes to what aspect(s) to the wrinkles is/are meant by the term “improving”.
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 16-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for administering a seaweed extract and 1-(2-hydroxyethyl)-2-imidazolidinone promoting proliferation of epidermal stem cells and improving skin barrier function of the skin of a subject, does not reasonably provide enablement for preventing wrinkles. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method for promoting proliferation of epidermal stem cells; and/or preventing or improving wrinkles; and/or improving skin barrier function of skin of a subject, comprising applying a composition comprising a heparanase/MMP-9 inhibitor; and a seaweed extract to the skin of a subject. Thus, the claims taken together with the specification imply that applying to the skin of a subject a composition comprising a heparanase/MMP-9 inhibitor and a seaweed extract promotes proliferation of epidermal stem cells, prevents or improves wrinkles, and improves skin barrier function of skin of a subject. The examiner interprets the term “preventing” in claim 16 as preventing in an absolute sense, not merely inhibiting, decreasing, attenuating, or delaying.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Iriyama (EP 3530750 A1) recites “A cosmetic method comprising administration of at least one extract selected from the group consisting of brown algae, red algae and green algae, or 1-(2-hydroxyethyl)-2-imidazolidinone, thereby enhancing expression of laminin 511 in the epidermis, wherein the effect of promoting expression of laminin 511 inhibits reduction or promotes increase in epidermal basal stem cells” (page 4, lines 2-5). The compound or 1-(2-hydroxyethyl)-2-imidazolidinone is disclosed by Iriyama as a heparanase inhibitor (Iriyama, Figure 8) and an MMP-9 inhibitor (Iriyama, Figure 9). Therefore, the disclosure of Iriyama supports administration of a seaweed extract and -(2-hydroxyethyl)-2-imidazolidinone having an effect of inhibiting reduction or promoting increase in epidermal basal stem cells. Furthermore, Iriyama does not disclose preventing wrinkles in the absolute sense, over the course of an entire lifetime, although wrinkle formation would be reasonably inhibited through the inhibition of heparanase and MMP-9 degrading the extracellular matrix.
Since the effects of the components of the instantly claimed administered composition over the course of an entire lifetime remains largely unsolved, means for preventing wrinkles is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high. Iriyama has disclosed substances promoting expression of laminin 511, inhibiting reduction or promoting increase in epidermal basal stem cells (page 4, lines 2-5).
Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided applying to the skin a combination of 1-(2-hydroxyethyl)-2-imidazolidinone and Argelex (an extract of green, red, and brown algae) promoting the proliferation of epidermal stem cells, and, as a reasonable effect, improving skin barrier function of the skin. However, the specification does not provide applying to the skin a combination of heparanase or MMP-9 inhibitor and Argelex (an extract of green, red, and brown algae) with the effect of preventing wrinkles.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Iriyama and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to prevent wrinkles; by applying a composition comprising a heparanase/MMP-9 inhibitor; and a seaweed extract to the skin of a subject.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11564959. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following overlapping processes and skin treatments.
Instant claims 16-20 and reference claims 1-4 both recite a process in which a seaweed extract (an extract of brown algae, red algae, or green algae) is administered to a subject, and both recite a process in which a heparanase or MMP-9 inhibitor (1-(2-Hydroxyethyl)-2-imidazolidinone, in view of reference figures 8 and 9) is administered to a subject. Although the reference application does not explicitly recite administering a combination of a seaweed extract and a heparanase or MMP-9 inhibitor, these components would be obvious to combine because they are both are implied as stabilizing epidermal basal membrane in the subject (reference claim 1), the motivation to combine these elements being their common utility for stabilizing epidermal basal membrane in the subject. Application to the skin (instant claim 16) would have been obvious to try considering that the reference process is directed toward stabilizing epidermal basal membrane in the subject (reference claim 1), and because the art recognizes the route of topical application to the skin for skin treatment.
Claims 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/068406 (document ID US 20230210928 A1) (primary reference application) in view of Iriyama and Tanno (US 20190275094 A1) (secondary reference, Cite No. A1 on the IDS received on May 2nd, 2024).
Both instant claims 16-20 and primary reference claims 1-17 recite a process comprising administering a heparanase or MMP-9 inhibitor to a subject (1-(2-Hydroxyethyl)-2-imidazolidinone, in view of primary reference figures 8 and 9).
Instant claims 16-20 are distinguished from primary reference claims 1-17 in that primary reference claims 1-17 do not explicitly recite administering a seaweed extract (instant claims 16-18); including an extract of red, greed, and brown algae (instant claims 19 and 20). However, primary reference claim 12 recites "wherein said administering stabilizes an epidermal basal membrane in the subject". The secondary reference recites "At least one extract selected from the group consisting of brown algae, red algae and green algae, or 1-(2-hydroxyethyl)-2-imidazolidinone for use in anti-aging treatment via stabilizing the epidermal basal membrane" (US 20190275094 A1, paragraph [0042]). Therefore, a person of skill in the art would have had suggestion to include administration of a seaweed extract, including an extract of green, red, and brown algae, in the invention recited in primary reference claims 1-17, considering the aim of stabilizing an epidermal basal membrane in the subject (primary reference claim 12; instant claims 16-20). A person of skill in the art would have also been motivated to combine at least one extract selected from the group consisting of brown algae, red algae and green algae; and 1-(2-hydroxyethyl)-2-imidazolidinone; because these substances can be used for this same purpose of stabilizing the epidermal basal membrane (US 20190275094 A1, paragraph [0042]; primary reference claims 1-17; instant claims 16-20).
Furthermore, administration by application to the skin of the subject (instant claim 16) would be obvious to try in view of primary reference claims 8-14, 16, and 17, which recites effects of administration on epidermal stem cells (primary reference claims 8-11, 16, and 17) and an epidermal basal membrane (primary reference claims 12-14); and because the art recognizes the route of topical application to the skin for skin treatment.
This is a provisional nonstatutory double patenting 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.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Iriyama and Tanno (EP 3530750 A1), abbreviated "Iriyama".
Claim 16 recites “A method for promoting proliferation of epidermal stem cells; and/or preventing or improving wrinkles; and/or improving skin barrier function of skin of a subject, comprising: applying the composition of claim 11 to the skin of the subject in need thereof, wherein the composition comprises: a heparanase/MMP-9 inhibitor; and a seaweed extract”. Claim 17 recites “The method according to claim 16, wherein the method is a non-therapeutic cosmetic method”. Claim 18 recites “The method according to claim 16, wherein the heparanase/MMP-9 inhibitor is 1-(2-hydroxyethyl)-2-imidazolidinone”. Claim 19 recites “The method according to claim 16, wherein the seaweed extract is a mixed extract of brown algae, red algae and green algae, or Argelex”. Claim 20 recites “The method according to claim 16, wherein the heparanase/MMP-9 inhibitor is 1-(2-hydroxyethyl)-2-imidazolidinone and the seaweed extract is Argelex”.
The applicant is notified that when reading the preamble in the context of the entire claim, the recitation "a method for promoting proliferation of epidermal stem cells; and/or preventing or improving wrinkles; and/or improving skin barrier function of skin of a subject" (instant claim 16) is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Iriyama recites “A cosmetic method comprising administration of at least one extract selected from the group consisting of brown algae, red algae and green algae, or 1-(2-hydroxyethyl)-2-imidazolidinone, thereby enhancing expression of laminin 511 in the epidermis, wherein the effect of promoting expression of laminin 511 inhibits reduction or promotes increase in epidermal basal stem cells” (page 4, lines 2-5; instant claims 16-20). Although Iriyama does not explicitly recite this method as a method comprising application of the recited materials to the skin of a subject, one of skill in the art would have been motivated to apply the materials to the skin because the target biological effect is in the skin (epidermal basal skin cells; instant claim 16). The “at least one extract selected from the group consisting of brown algae, red algae and green algae” recited above encompasses the composition Argelex, described by the applicant as “a mixed extract from brown algae, red algae and green algae” (instant specification [0016]; instant claims 19 and 20). The compound or 1-(2-hydroxyethyl)-2-imidazolidinone is disclosed by Iriyama as a heparanase inhibitor (Iriyama, Figure 8) and an MMP-9 inhibitor (Iriyama, Figure 9).
Although Iriyama does not explicitly recite combining the 1-(2-hydroxyethyl)-2-imidazolidinone with a seaweed extract in the composition applied to the skin, a person of skill in the art would have been motivated to do so as both substances were known for enhancing expression of laminin 511 in the epidermis (Iriyama page 4, lines 2-5; instant claim 16). It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients for their known benefit since each is well known in the art for the same purpose and for the following reasons: all of the components of the composition administered in the claimed method of Iriyama are individually thought to possess activities for enhancing expression of laminin 511. In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). The Supreme Court thus implicitly endorsed the principle, stated in In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (citations omitted), that: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art” (instant claim 16).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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, Anand Desai can be reached at (571) 272-0947. 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.
/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
Prosecution Insights