Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 1-18 are objected to because of the following informalities: For claims 1-18:
Claim 1 recites the limitation:
“at least partially affecting normal healing of the perforations”
Applicant refers to “the perforations”. However, before this limitation the term “perforations” is never stated. This is not indefinite, because the only interpretation is that perforations refer to the “pores” recited previously in this claim. However, for clarity applicant should refer to the same element. For example, applicant could state:
“at least partially affecting normal healing of the pores in the connective tissue”
Claims 2-18 are objected to based on dependency to claim 1.
Additionally for claim 17-18:
Claim 17 recites the limitation:
“wherein the two-dimensional linear array of pores forms an nxm matrix, wherein n is the number of pores in each row and m is the number of pores in each row.”
This appears to be a typo as both n and m are both described as being rows instead of rows and columns. Therefore claim 17 should be changed to recite:
“wherein the two-dimensional linear array of pores forms an nxm matrix, wherein n is the number of pores in each row and m is the number of pores in each column.”
Claim 18 recites the limitation:
“The method of claim 3, wherein the nxm matrix is at least a 3x3 matrix.”
This is interpreted as having a typo as it is clearly further defining claim 17 and, thus should be changed to:
“The method of claim 17, wherein the nxm matrix is at least a 3x3 matrix.
Appropriate correction is required.
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 2-16 and 18 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 pre-AIA the applicant regards as the invention. The limitation “connective tissue” renders the claims indefinite. Paragraph 3 of applicant’s specification received on 1/17/2025 recites: “Connective tissue is tissue that supports and connects other tissues and parts of the body.” Based on this section connective tissue is broadly defined which is fine which is why claims 1 and 17 are not indefinite. However, with respect to claims 2-16 there are not clear boundaries for what specifically is the connective tissue with the recited tissue. For example, claim 7 recites “wherein the connective tissue is bone”. Does the connective tissue encompass the entire bone or a subsection of the bone? Similarly, to this example, the rest of these claims do not provide a clear boundary as to what specifically is the target. This is particularly important as a limitation of independent claim 1 recites that a pore 90% of the depth of the target is created. 90% of the entire bone thickness vs 90% a subsection of bone thickness can make a big difference as to what is being claimed. For this examination, any pore or hole that has depth of at least 90% in specifically the targeted part of the claimed connective tissue is interpreted as reciting the claimed limitation.
If this interpretation taken is applicant’s intended interpretation, then if applicant amends the limitation of claim 1 of:
“forming a two-dimensional array of pores in the connective tissue to at least 90% of the depth of the connective tissue”
To recite:
“forming a two-dimensional array of pores in the connective tissue to at least 90% of the depth of the targeted area of the connective tissue”
this would overcome this aspect of the current 112(b) rejection to the claims 2-16 and 18.
Additionally, paragraph 3 of applicant’s disclosure recites “The loss of flexibility or alterations of fundamental properties of connective tissue may change the overall desired properties of the connective tissue and may also undesirably affect the surrounding tissues, structures, organs, or systems related to the connective tissue.” Based on this section of applicant’s disclosure it appears that connective tissue can be interpreted as a separate structure from the rest of the recited tissue. For example, with claim 3, applicant recites “wherein the connective tissue is kidney tissue”. However, the kidney is an organ and based on this section applicant appears to indicating that the tissue is connected/near the kidney. Therefore, the interpretation of claims in light of the specification are not completely clear. Back to the example of claim 3, it’s not completely clear if applicant is claiming tissue surrounding the kidney or the tissue in the kidney and similarly for the rest of the claims 2-16. For this examination, the most reasonable interpretation is that the tissue is part of the structure. For example, with claim 3, the connective tissue is interpreted as part of kidney. The rest of claims 2-16 are interpreted similarly to the example of claim 3. Regardless if this is applicant’s interpretation or not, applicant needs to clarify what is being claimed here.
Claim 18 is also rejected under 35 USC 112(b) based on dependency to claim 3. However, as outlined in the objection to claim 18 above, the dependency appears to be a typo, if claim 18 is corrected as advised in the objection section above, the 112(b) rejection to claim 18 will be overcome.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8348932 (hereafter known as Pat ‘932). Although the claims at issue are not identical, they are not patentably distinct from each other because, Claim 1 of US pat 8348932 anticipates all the limitations of claim 1 of this application as outlined below:
Claim 1:
A method of treating connective tissue [see claim 1 of Pat ‘932… “A method of treating connective tissue”] of comprising:
forming a two-dimensional array of pores in the connective tissue to at least 90% of the depth of the connective tissue [see claim 1 of Pat ‘932… “forming a first closely arranged, two-dimensional array of pores perforations in the connective tissue to at least 90% of the depth of the connective tissue”]; and
at least partially affecting normal healing of the perforations [see claim 1 of Pat ‘932 “at least partially affecting normal healing of the pores”];
wherein the pores are arrayed according to rows and columns [see claim 1 of Pat ‘932… “wherein the pores are arrayed according to rows and columns”]; and
wherein the pores are arranged in a polygonal shape [see claim 1 of Pat ‘932… “wherein the pores are arranged in a polygonal shape”].
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 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 pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1 and 17 are is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Lin et al (US 20050279369) hereafter known as Lin.
Regarding Claim 1
Lin discloses
A method of treating [see title of Lin… “Method And Apparatus For The Treatment Of Presbyoipia And Glaucoma By Ciliary Body Ablation”] connective tissue [see element 17 and para 42... “sclera layer” is at least connective tissue] comprising:
forming a two-dimensional array [see Fig. 6b… there are 12 spots with 6 rows and 2 columns which is at least a two-dimensional array] of pores [see each spot in Fig. 6B] in the connective tissue to at least 90% of the depth of the connective tissue [see Figs 4 which shows the ablation area (element 32) going completely through element 17 (the sclera)]; and
at least partially affecting normal healing of the perforations [see para 24… see “post-operation medication such as pilocarpine or medicines with similar nature that may cause ciliary body contraction to stable and/or enhance the post-operative results
after the ablation-method” use of medication for healing at least recites the claimed limitation] ;
wherein the pores are arrayed according to rows and columns [see Fig. 6b… there are 12 spots with 6 rows and 2 columns];
and wherein the pores are arranged in a polygonal shape [see Fig. 6b which makes a rhombus shape which is at least a polygonal shape].
Regarding Claim 17, see labelled Fig. 6B directly below
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Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 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, 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 for establishing a background for determining obviousness under pre-AIA 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.
Claim 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lin.
Lin discloses the invention substantially as claimed including all the limitations of claim 1.
However, Lin discloses a 6X2 matrix of pores [see Fig. 6B of Lin] and therefore does not disclose a 3x3 matrix of pores as claimed.
At the time the invention was made it would have been a matter of design choice to use a 3x3 matrix instead of a 6X2 matrix because applicant does not provide any specific reason why pores in a 3x3 matrix would perform better than a different matrix configuration such as the 6x2 matrix used by Lin. Furthermore, since the same result of increased flexibility will occur [see para 18 of Lin see “A further objective is to provide a treatment for presbyopia”… presbyopia is a condition where the eye loses elasticity and becomes rigid… therefore treatment of presbyopia results in increased elasticity therefore an increase in flexibility], one of ordinary skill would understand a different matrix configuration would perform the same result.
Claims 2-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lin as applied to claim 1 above, and further in view of Sand et al (US 20030028228) hereafter known as Sand.
Lin discloses the invention substantially as claimed including all the limitations of claim 1 which includes increase of flexibility in the eye [see para 18 of Lin see “A further objective is to provide a treatment for presbyopia”… presbyopia is a condition where the eye loses elasticity and becomes rigid… therefore treatment of presbyopia results in increased elasticity therefore an increase in flexibility].
However, Lin is directed only to the treatment of connective tissue in the eye and therefore fails to disclose treating tissue of other parts of the body including connective tissue that is ear tissue, kidney tissue, ovary tissue, aponeurose tissue, neural sheath tissue, bone, cartilage, ligament, tendon, dura mater, lymph node tissue, spleen tissue, vascular vessel tissue, heart tissue, or muscle tissue as recited in claims 2-16.
Sand discloses that the basic structural fiber of all connective tissues is collagen [see para 28…The basic structural fiber in all connective tissues is collagen.] including the eye [see abstract of Sand… “treatment of ocular collagen connective tissue”].
It would have been obvious to one having ordinary skill to apply Lin’s device to treat other connective tissue outside the eye including ear tissue, kidney tissue, ovary tissue, aponeurose tissue, neural sheath tissue, bone, cartilage, ligament, tendon, dura mater, lymph node tissue, spleen tissue, vascular vessel tissue, heart tissue, or muscle tissue as recited in claims 2-16 because all of these tissues are composed of the same building block of collagen. Therefore, since the same composition is being treated, one would expect a predictable result of an increase in flexibility by applying pores that go through an entire layer of connective tissue throughout the body.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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